A Novel Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Bictegravir, Emtricitabine and Tenofovir in Pure and Fixed Dose Combination

G. Vijay Swaroop Singh; T.E. Divakar

doi:10.14233/ajomc.2019.AJOMC-P163

Download

PDF

Abstract

A novel, simple, precise, accurate stability indicating liquid chromatography method was developed for the separation and simultaneous quantification of bictegravir, emtricitabine, tenofovir in bulk drug and pharmaceutical formulations. Separation was achieved on ProntoSILHypersorb ODS C18 column using mobile phase of 0.1 M sodium perchlorate, methanol in the ratio of 65:35 (v/v), pH 4.8 at a flow rate of 1.0 mL/min and UV detection was monitored at a wavelength of 258 nm. In these conditions, well resolved peaks were observed with acceptable system suitability at a retention time of 4.6 min for bictegravir, 7.0 min for emtricitabine and 10.1 min for tenofovir. Very high correlated linearity range was found to be 5-30 μg/mL for bictegravir, 20-120 μg/mL for emtricitabine and 2.5-15 μg/mL for tenofovir. The method can separate and identify the unknown degradation compounds formed during stress degradation study.

Keywords

Bictegravir Emtricitabine Tenofovir HPLC method Forced degradation

How to Cite

Vijay Swaroop Singh, G., & Divakar, T. (2019). A Novel Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Bictegravir, Emtricitabine and Tenofovir in Pure and Fixed Dose Combination. Asian Journal of Organic & Medicinal Chemistry, 4(1), 7–13. https://doi.org/10.14233/ajomc.2019.AJOMC-P163

Download Citation

References

K. White, T. Cihlar and M.D. Miller, Potent Activity of Bictegravir (BIC; GS-9883), A Novel Unboosted HIV-1 Integrase Strand Transfer Inhibitor (INSTI), Against Patient Isolates with INSTI-Resistance. American Society for Microbiology (ASM) Microbe, Boston, MA June 16-20, (2016).
M. Tsiang, G.S. Jones, J. Goldsmith, A. Mulato, D. Hansen, E. Kan, L. Tsai, R.A. Bam, G. Stepan, K.M. Stray, A. Niedziela-Majka, S.R. Yant, H. Yu, G. Kukolj, T. Cihlar, S.E. Lazerwith, K.L. White and H. Jin, Antiviral Activity of Bictegravir (GS-9883), A Novel Potent HIV-1 Integrase Strand Transfer Inhibitor with an Improved Resistance Profile, Antimicrob. Agents Chemother., 60, 7086 (2016); https://doi.org/10.1128/AAC.01474-16.
J. Gallant, M. Thompson, E. DeJesus, G.W. Voskuhl, X. Wei, H. Zhang, K. White, A. Cheng, E. Quirk and H. Martin, Antiviral Activity, Safety, and Pharmacokinetics of Bictegravir as 10-Day Monotherapy in HIV-1–Infected Adults, J. Acquir. Immune Defic. Syndr., 75, 61 (2017); https://doi.org/10.1097/QAI.0000000000001306.
S.G. Lim, T.M. Ng, N. Kung, Z. Krastev, M. Volfova, P. Husa, Samuel S. Lee, S. Chan, M.L. Shiffman, M.K. Washington, A. Rigney, J. Anderson, E. Mondou, A. Snow, J. Sorbel, R. Guan and F. Rousseau, A Double-blind Placebo-Controlled Study of Emtricitabine in Chronic Hepatitis B, Arch. Intern. Med., 166, 49 (2006); https://doi.org/10.1001/archinte.166.1.49.
P. Martin, D.T. Lau, M.H. Nguyen, H.L. Janssen, D.T. Dieterich, M.G. Peters and I.M. Jacobson, A Treatment Algorithm for the Management of Chronic Hepatitis B Virus Infection in the United States: 2015 Update, Clin. Gastroenterol. Hepatol., 13, 2071 (2015); https://doi.org/10.1016/j.cgh.2015.07.007.
Gurinder Singh and Roopa S. Pai, ISRN Chromatography,1 (2013).
A. Narendra, D. Deepika and M.M. Annapurna, Determination of Emtri-citabine by Derivative Spectrophotometric Method in Pharmaceutical Dosage Forms, Chem. Sci. Trans., 2, 978 (2013); https://doi.org/10.7598/cst2013.486.
P.T. Nagaraju, K.P. Channabasavaraj and P.T. Shantha Kumar, Develop-ment and Validation of Spectrophotometric Method for Estimation of Emtricitabine in Tablet Dosage Form, Int. J. Chemtech Res., 3, 23 (2011).
K.V. Sri, M. Madhuri and G.V.Jain, Multivariate UV-Visible Spectro-photometric Method for the Estimation of Emtricitabine in Bulk Form, Int. J. Pharm. Dev. Technol., 5, 89 (2015).
P. Kumar, D.S. Mittan and N. Kumar, Development of UV Spectro-scopic Method for the Estimation of Tenofovir in Bulk and Solid Dosage Forms, Anal. Chem.: An Indian J., 13, 33 (2013).
P.S. Khan, P.R. Reddy and V.K. Reddy, Spectrophotometric Methods for the Determination of Emtricitabine in Bulk and in its Pharmaceutical Formulations using Aromatic Aldehydes as Chromogenic Reagents, Der Pharm. Sinica, 5, 10 (2014).
S.I. Pasha, M. Taqui, V. Nikhila, D. Tirupathi, A. Shravankumar and T. Gopi, J. Pharm. Ind. Res., 2, 68 (2012).
G. Gnanarajan, A.K. Gupta, V. Juyal, P. Kumar, P.K. Yadav and P. Kailash, A Validated Method for Development of Tenofovir as API and Tablet Dosage Forms by UV Spectroscopy, J. Young Pharm., 1, 351 (2009); https://doi.org/10.4103/0975-1483.59326.
M. Sasikala, M.T. Deepthi, K.V. Kumar and N.M. Raja B., Development and Validation of UV Spectrophotometric Method for the Simultaneous Estimation of Tenofovir Disproxil Fumarate and Emtricitabine in Tablet Dosage Form by Derivative Spectroscopic Method, Int. Bull. Drug. Res., 3, 20 (2013).
A. Behera, A. Parida, A.K. Meher, D. Gowri, S.K.M. Sankar and S.C. Si, Development and Validation of Spectrophotometric Method for Deter-mination of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Tablet Fosage Form, Int. J. Pharmtech. Res., 3, 1874 (2011).
H.K. Ashour and T.S. Belal, New Simple Spectrophotometric Method for Determination of the Antiviral Mixture of Emtricitabine and Tenofovir Disoproxil Fumarate, Arab. J. Chem., 10, 1741 (2017); https://doi.org/10.1016/j.arabjc.2013.06.024.
V.P. Choudhari, S. Ingale, S.R. Gite, D.D. Tajane, V.G. Modak and A. Ambekar, Spectrophotometric Simultaneous Determination of Tenofovir Disoproxil Fumarate and Emtricitabine in Combined Tablet Dosage Form by Ratio Derivative, First Order Derivative and Absorbance Corrected Methods and its Application to Dissolution Study, Pharm. Methods, 2, 47 (2011); https://doi.org/10.4103/2229-4708.81096.
S. Venkatesan and N. Kannappan, Simultaneous Spectrophotometric Method for Determination of Emtricitabine and Tenofovir Disoproxil Fumarate in Three-Component Tablet Formulation Containing Rilpivirine Hydrochloride, Int. Schlor. Res. Notices, 2014, Article ID 541727 (2014); https://doi.org/10.1155/2014/541727.
K. Anandakumar, K. Kannan and T. Vetrichelvan, Development and Validation of Emtricitabine and Tenofovir Disoproxil in Pure and in Fixed Dose Combination by UV Spectrophotometry, Dig. J. Nanomater. Biostruct., 6, 1085 (2011).
S.A. Ghorpade, M.S. Sali, A.H. Kategaonkar, D.M. Patel, V.P. Choudhari and B.S. Kuchekar, Simultaneous Determination of Emtricitabine and Tenofovir by Area Under Curve and Dual Wavelength Spectrophoto-metric Method, J. Chil. Chem. Soc., 55, 115 (2010); https://doi.org/10.4067/S0717-97072010000100027.
N.M.D. Akram and M. Umamahesh, A New Validated RP-HPLC Method for the Determination of Emtricitabine and Tenofovir AF in its Bulk and Pharmaceutical Dosage Forms, J. Chem. Pharm. Sci., 10, 54 (2017).
R. Sharma and P. Gupta, A Validated RP-HPLC Method for Simulat-aneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in a Tablet Dosage Form, Eur. J. Anal. Chem., 4, 276 (2009).
B.R.R. Yenumula, M.R. Singampalli and B.S.R. Challa, Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Tablet Dosage Form by Reverse Phase High-performance Liquid Chromatog-raphy, Int. J. Anal. Techniq., 1, 1 (2015).
Sk Mastanamma, D.V. Reddy, P. Saidulu and M. Varalakhimi, Develop-ment and Validation of Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Emtricitabine, Tenofovir, Alafenamide Bulk and their Combined Dosage Form, J. Chem. Pharm. Res., 9, 70 (2017).
B.P. Badgujar, M.P. Mahajan and S.D. Sawant, Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Tenofovir Alafenamide and Emtricitabine in Bulk and Tablet Dosage Form, Int. J. Chemtech Res., 10, 731 (2017).
S.M. Illamola, E. Valade, D. Hirt, E. Dulioust, Y. Zheng, J.P. Wolf and J.M. Tréluyer, Development and Validation of a LC-MS/MS Method for the Quantification of Tenofovir and Emtricitabine in Seminal Plasma, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 1033-1034, 234 (2016); https://doi.org/10.1016/j.jchromb.2016.08.011.
T. Delahunty, L. Bushman, B. Robbins and C.V. Fletcher, The Simultan-eous Assay of Tenofovir and Emtricitabine in Plasma using LC/MS/MS and Isotopically Labeled Internal Standards, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 877, 1907 (2009); https://doi.org/10.1016/j.jchromb.2009.05.029.
N.A. Gomes, V.V. Vaidya, A. Pudage, S.S. Joshi and S.A. Parekh, Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Method for Simultaneous Determination of Tenofovir and Emtricitabine in Human Plasma and its Application to a Bioequivalence Study, J. Pharm. Biomed. Anal., 48, 918 (2008); https://doi.org/10.1016/j.jpba.2008.07.022.
C. Runja, P.R. Kumar and S.R. Avanapu, A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form, J. Chromatogr. Sci., 54, 759 (2016); https://doi.org/10.1093/chromsci/bmw004.
U. Harini and A.K.M. Pawar, Development and Validation of Stability Indicating Simultaneous UV-spectrophotometric Method for Determi-nation of Emtricitabine, Tenofovir, Disoproxil Fumarate, Cobicistat and Elvitegravir in Pure and Pharmaceutical Dosage Form, Asian J. Pharm. Clin. Res., 11, 177 (2018); https://doi.org/10.22159/ajpcr.2018.v11i4.22897.
R.K. Gummaluri, T.V.N. Parthasarathi and G. Anjanamadhulika, Simul-taneous Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Tablets by HPLC, Indian J. Pharm. Sci., 78, 532 (2016); https://doi.org/10.4172/pharmaceutical-sciences.1000148.
S. Venkatesan, N. Kannappan and S.S. Mannemala, Stability-Indicating HPLC Method for the Simultaneous Determination of HIV Tablet Contain-ing Emtricitabine, Tenofovir Disoproxil Fumarate and Rilpivirine Hydro-chloride in Pharmaceutical Dosage Forms, Int. Schol. Res. Notices, 2014, Article ID 849149 (2014).
A.P. Panigrahy and A.S.K. Reddy, A Novel Validated RP-HPLC Method for the Simultaneous Estimation of Emtricitabine, Tenofovir Disoproxil Fumarate and Rilpivirine in Bulk and Pharmaceutical Tablet Dosage Forms, Der Pharm. Lett., 7, 303 (2015).
C. Palavan, L.A. Ramaprasad and P. Srinivasu, A New RP-HPLC Method for the Simultaneous Estimation of Abacavir, Lamivudine and Zidovudine in Tablet Dosage Forms, Am. J. Pharmtech. Res., 3, 754 (2013).
A. Ramaswamy and A.S.A.G. Dhas, Development and Validation of Analy-tical Method for Quantitation of Emtricitabine, Tenofovir, Efavirenz based on HPLC, Arab. J. Chem., 11, 275 (2018); https://doi.org/10.1016/j.arabjc.2014.08.007.
H.I. Al-Johar, M.M. Maher, N.Z. Al-Zoman, D.J. Al-Shammary and H. Al-Showiman, A Stability-Indicating Capillary Electrophoresis Method for the Determination of Emtricitabine and Tenofovir Disoproxil Fumarate in Pharmaceutical Tablets, Acta Chromatogr., 29, 469 (2017); https://doi.org/10.1556/1326.2017.00057.
M. Madhuri, K.V. Sri and G.V. Jain, Simultaneous Estimation and Validation of Tenofovir Disproxil Fumarate, Emtricitabine and Rilpivirine Hydrochloride in Pharmaceutical Dosage Form by UV-Spectrophotometry, Indo-Am. J. Pharm. Res., 4, 5864 (2014).
P.D. Hamarapurkar and A.N. Parate, HPLC Method for the Determina-tion of Emtricitabine and Related Degradation Substances, J. Chromatogr. Sci., 51, 419 (2013); https://doi.org/10.1093/chromsci/bms157.
A.P. Nikalje, M. Shahed, M. Dehghan and M. Joshi, HPTLC Method for the Simultaneous Estimation of Emtricitabine and Tenofovir in Tablet Dosage Form, Indian J. Pharm. Sci., 71, 95 (2009); https://doi.org/10.4103/0250-474X.51951.
J. Saminathan and T. Vetrichelvan, Development and Validation of HPTLC Method for Simultaneous Estimation of Emtricitabine, Rilpi-virine and Tenofovir Disoproxil Fumarate in Combined Dosage form, Bangladesh Pharm. J., 19, 114 (2016); https://doi.org/10.3329/bpj.v19i1.29247.
P.K. Prathipati, S. Mandal and C.J. Destache, Simultaneous Quantifi-cation of Tenofovir, Emtricitabine, Rilpivirine, Elvitegravir and Dolutegravir in Mouse Biological Matrices by LC-MS/MS and Its Application to a Pharmacokinetic Study, J. Pharm. Biomed. Anal., 129, 473 (2016); https://doi.org/10.1016/j.jpba.2016.07.040.
B.V. Purnima, T.V.B. Reddy, Y.S. Rao, G. Ramu and D. Ramachandran, Stability Indicating RP-UPLC Method for Assay of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Dosage Forms, Am. J. Anal. Chem., 6, 807 (2015); https://doi.org/10.4236/ajac.2015.610077.
S.I. Pasha, M.B. Varanasi and I. Mohammed, Stability Indicating RP-UPLC-PDA Method Development, Validation of Multi Drug Combi-nation of Emtricitabine, Tenofovir Alafenamide and Rilpivirine in Bulk Drug and its Tablet Formulation, Orient. J. Chem., 33, 925 (2017); https://doi.org/10.13005/ojc/330243.

References

K. White, T. Cihlar and M.D. Miller, Potent Activity of Bictegravir (BIC; GS-9883), A Novel Unboosted HIV-1 Integrase Strand Transfer Inhibitor (INSTI), Against Patient Isolates with INSTI-Resistance. American Society for Microbiology (ASM) Microbe, Boston, MA June 16-20, (2016).

M. Tsiang, G.S. Jones, J. Goldsmith, A. Mulato, D. Hansen, E. Kan, L. Tsai, R.A. Bam, G. Stepan, K.M. Stray, A. Niedziela-Majka, S.R. Yant, H. Yu, G. Kukolj, T. Cihlar, S.E. Lazerwith, K.L. White and H. Jin, Antiviral Activity of Bictegravir (GS-9883), A Novel Potent HIV-1 Integrase Strand Transfer Inhibitor with an Improved Resistance Profile, Antimicrob. Agents Chemother., 60, 7086 (2016); https://doi.org/10.1128/AAC.01474-16.

J. Gallant, M. Thompson, E. DeJesus, G.W. Voskuhl, X. Wei, H. Zhang, K. White, A. Cheng, E. Quirk and H. Martin, Antiviral Activity, Safety, and Pharmacokinetics of Bictegravir as 10-Day Monotherapy in HIV-1–Infected Adults, J. Acquir. Immune Defic. Syndr., 75, 61 (2017); https://doi.org/10.1097/QAI.0000000000001306.

S.G. Lim, T.M. Ng, N. Kung, Z. Krastev, M. Volfova, P. Husa, Samuel S. Lee, S. Chan, M.L. Shiffman, M.K. Washington, A. Rigney, J. Anderson, E. Mondou, A. Snow, J. Sorbel, R. Guan and F. Rousseau, A Double-blind Placebo-Controlled Study of Emtricitabine in Chronic Hepatitis B, Arch. Intern. Med., 166, 49 (2006); https://doi.org/10.1001/archinte.166.1.49.

P. Martin, D.T. Lau, M.H. Nguyen, H.L. Janssen, D.T. Dieterich, M.G. Peters and I.M. Jacobson, A Treatment Algorithm for the Management of Chronic Hepatitis B Virus Infection in the United States: 2015 Update, Clin. Gastroenterol. Hepatol., 13, 2071 (2015); https://doi.org/10.1016/j.cgh.2015.07.007.

Gurinder Singh and Roopa S. Pai, ISRN Chromatography,1 (2013).

A. Narendra, D. Deepika and M.M. Annapurna, Determination of Emtri-citabine by Derivative Spectrophotometric Method in Pharmaceutical Dosage Forms, Chem. Sci. Trans., 2, 978 (2013); https://doi.org/10.7598/cst2013.486.

P.T. Nagaraju, K.P. Channabasavaraj and P.T. Shantha Kumar, Develop-ment and Validation of Spectrophotometric Method for Estimation of Emtricitabine in Tablet Dosage Form, Int. J. Chemtech Res., 3, 23 (2011).

K.V. Sri, M. Madhuri and G.V.Jain, Multivariate UV-Visible Spectro-photometric Method for the Estimation of Emtricitabine in Bulk Form, Int. J. Pharm. Dev. Technol., 5, 89 (2015).

P. Kumar, D.S. Mittan and N. Kumar, Development of UV Spectro-scopic Method for the Estimation of Tenofovir in Bulk and Solid Dosage Forms, Anal. Chem.: An Indian J., 13, 33 (2013).

P.S. Khan, P.R. Reddy and V.K. Reddy, Spectrophotometric Methods for the Determination of Emtricitabine in Bulk and in its Pharmaceutical Formulations using Aromatic Aldehydes as Chromogenic Reagents, Der Pharm. Sinica, 5, 10 (2014).

S.I. Pasha, M. Taqui, V. Nikhila, D. Tirupathi, A. Shravankumar and T. Gopi, J. Pharm. Ind. Res., 2, 68 (2012).

G. Gnanarajan, A.K. Gupta, V. Juyal, P. Kumar, P.K. Yadav and P. Kailash, A Validated Method for Development of Tenofovir as API and Tablet Dosage Forms by UV Spectroscopy, J. Young Pharm., 1, 351 (2009); https://doi.org/10.4103/0975-1483.59326.

M. Sasikala, M.T. Deepthi, K.V. Kumar and N.M. Raja B., Development and Validation of UV Spectrophotometric Method for the Simultaneous Estimation of Tenofovir Disproxil Fumarate and Emtricitabine in Tablet Dosage Form by Derivative Spectroscopic Method, Int. Bull. Drug. Res., 3, 20 (2013).

A. Behera, A. Parida, A.K. Meher, D. Gowri, S.K.M. Sankar and S.C. Si, Development and Validation of Spectrophotometric Method for Deter-mination of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Tablet Fosage Form, Int. J. Pharmtech. Res., 3, 1874 (2011).

H.K. Ashour and T.S. Belal, New Simple Spectrophotometric Method for Determination of the Antiviral Mixture of Emtricitabine and Tenofovir Disoproxil Fumarate, Arab. J. Chem., 10, 1741 (2017); https://doi.org/10.1016/j.arabjc.2013.06.024.

V.P. Choudhari, S. Ingale, S.R. Gite, D.D. Tajane, V.G. Modak and A. Ambekar, Spectrophotometric Simultaneous Determination of Tenofovir Disoproxil Fumarate and Emtricitabine in Combined Tablet Dosage Form by Ratio Derivative, First Order Derivative and Absorbance Corrected Methods and its Application to Dissolution Study, Pharm. Methods, 2, 47 (2011); https://doi.org/10.4103/2229-4708.81096.

S. Venkatesan and N. Kannappan, Simultaneous Spectrophotometric Method for Determination of Emtricitabine and Tenofovir Disoproxil Fumarate in Three-Component Tablet Formulation Containing Rilpivirine Hydrochloride, Int. Schlor. Res. Notices, 2014, Article ID 541727 (2014); https://doi.org/10.1155/2014/541727.

K. Anandakumar, K. Kannan and T. Vetrichelvan, Development and Validation of Emtricitabine and Tenofovir Disoproxil in Pure and in Fixed Dose Combination by UV Spectrophotometry, Dig. J. Nanomater. Biostruct., 6, 1085 (2011).

S.A. Ghorpade, M.S. Sali, A.H. Kategaonkar, D.M. Patel, V.P. Choudhari and B.S. Kuchekar, Simultaneous Determination of Emtricitabine and Tenofovir by Area Under Curve and Dual Wavelength Spectrophoto-metric Method, J. Chil. Chem. Soc., 55, 115 (2010); https://doi.org/10.4067/S0717-97072010000100027.

N.M.D. Akram and M. Umamahesh, A New Validated RP-HPLC Method for the Determination of Emtricitabine and Tenofovir AF in its Bulk and Pharmaceutical Dosage Forms, J. Chem. Pharm. Sci., 10, 54 (2017).

R. Sharma and P. Gupta, A Validated RP-HPLC Method for Simulat-aneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in a Tablet Dosage Form, Eur. J. Anal. Chem., 4, 276 (2009).

B.R.R. Yenumula, M.R. Singampalli and B.S.R. Challa, Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Tablet Dosage Form by Reverse Phase High-performance Liquid Chromatog-raphy, Int. J. Anal. Techniq., 1, 1 (2015).

Sk Mastanamma, D.V. Reddy, P. Saidulu and M. Varalakhimi, Develop-ment and Validation of Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Emtricitabine, Tenofovir, Alafenamide Bulk and their Combined Dosage Form, J. Chem. Pharm. Res., 9, 70 (2017).

B.P. Badgujar, M.P. Mahajan and S.D. Sawant, Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Tenofovir Alafenamide and Emtricitabine in Bulk and Tablet Dosage Form, Int. J. Chemtech Res., 10, 731 (2017).

S.M. Illamola, E. Valade, D. Hirt, E. Dulioust, Y. Zheng, J.P. Wolf and J.M. Tréluyer, Development and Validation of a LC-MS/MS Method for the Quantification of Tenofovir and Emtricitabine in Seminal Plasma, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 1033-1034, 234 (2016); https://doi.org/10.1016/j.jchromb.2016.08.011.

T. Delahunty, L. Bushman, B. Robbins and C.V. Fletcher, The Simultan-eous Assay of Tenofovir and Emtricitabine in Plasma using LC/MS/MS and Isotopically Labeled Internal Standards, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 877, 1907 (2009); https://doi.org/10.1016/j.jchromb.2009.05.029.

N.A. Gomes, V.V. Vaidya, A. Pudage, S.S. Joshi and S.A. Parekh, Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Method for Simultaneous Determination of Tenofovir and Emtricitabine in Human Plasma and its Application to a Bioequivalence Study, J. Pharm. Biomed. Anal., 48, 918 (2008); https://doi.org/10.1016/j.jpba.2008.07.022.

C. Runja, P.R. Kumar and S.R. Avanapu, A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form, J. Chromatogr. Sci., 54, 759 (2016); https://doi.org/10.1093/chromsci/bmw004.

U. Harini and A.K.M. Pawar, Development and Validation of Stability Indicating Simultaneous UV-spectrophotometric Method for Determi-nation of Emtricitabine, Tenofovir, Disoproxil Fumarate, Cobicistat and Elvitegravir in Pure and Pharmaceutical Dosage Form, Asian J. Pharm. Clin. Res., 11, 177 (2018); https://doi.org/10.22159/ajpcr.2018.v11i4.22897.

R.K. Gummaluri, T.V.N. Parthasarathi and G. Anjanamadhulika, Simul-taneous Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Tablets by HPLC, Indian J. Pharm. Sci., 78, 532 (2016); https://doi.org/10.4172/pharmaceutical-sciences.1000148.

S. Venkatesan, N. Kannappan and S.S. Mannemala, Stability-Indicating HPLC Method for the Simultaneous Determination of HIV Tablet Contain-ing Emtricitabine, Tenofovir Disoproxil Fumarate and Rilpivirine Hydro-chloride in Pharmaceutical Dosage Forms, Int. Schol. Res. Notices, 2014, Article ID 849149 (2014).

A.P. Panigrahy and A.S.K. Reddy, A Novel Validated RP-HPLC Method for the Simultaneous Estimation of Emtricitabine, Tenofovir Disoproxil Fumarate and Rilpivirine in Bulk and Pharmaceutical Tablet Dosage Forms, Der Pharm. Lett., 7, 303 (2015).

C. Palavan, L.A. Ramaprasad and P. Srinivasu, A New RP-HPLC Method for the Simultaneous Estimation of Abacavir, Lamivudine and Zidovudine in Tablet Dosage Forms, Am. J. Pharmtech. Res., 3, 754 (2013).

A. Ramaswamy and A.S.A.G. Dhas, Development and Validation of Analy-tical Method for Quantitation of Emtricitabine, Tenofovir, Efavirenz based on HPLC, Arab. J. Chem., 11, 275 (2018); https://doi.org/10.1016/j.arabjc.2014.08.007.

H.I. Al-Johar, M.M. Maher, N.Z. Al-Zoman, D.J. Al-Shammary and H. Al-Showiman, A Stability-Indicating Capillary Electrophoresis Method for the Determination of Emtricitabine and Tenofovir Disoproxil Fumarate in Pharmaceutical Tablets, Acta Chromatogr., 29, 469 (2017); https://doi.org/10.1556/1326.2017.00057.

M. Madhuri, K.V. Sri and G.V. Jain, Simultaneous Estimation and Validation of Tenofovir Disproxil Fumarate, Emtricitabine and Rilpivirine Hydrochloride in Pharmaceutical Dosage Form by UV-Spectrophotometry, Indo-Am. J. Pharm. Res., 4, 5864 (2014).

P.D. Hamarapurkar and A.N. Parate, HPLC Method for the Determina-tion of Emtricitabine and Related Degradation Substances, J. Chromatogr. Sci., 51, 419 (2013); https://doi.org/10.1093/chromsci/bms157.

A.P. Nikalje, M. Shahed, M. Dehghan and M. Joshi, HPTLC Method for the Simultaneous Estimation of Emtricitabine and Tenofovir in Tablet Dosage Form, Indian J. Pharm. Sci., 71, 95 (2009); https://doi.org/10.4103/0250-474X.51951.

J. Saminathan and T. Vetrichelvan, Development and Validation of HPTLC Method for Simultaneous Estimation of Emtricitabine, Rilpi-virine and Tenofovir Disoproxil Fumarate in Combined Dosage form, Bangladesh Pharm. J., 19, 114 (2016); https://doi.org/10.3329/bpj.v19i1.29247.

P.K. Prathipati, S. Mandal and C.J. Destache, Simultaneous Quantifi-cation of Tenofovir, Emtricitabine, Rilpivirine, Elvitegravir and Dolutegravir in Mouse Biological Matrices by LC-MS/MS and Its Application to a Pharmacokinetic Study, J. Pharm. Biomed. Anal., 129, 473 (2016); https://doi.org/10.1016/j.jpba.2016.07.040.

B.V. Purnima, T.V.B. Reddy, Y.S. Rao, G. Ramu and D. Ramachandran, Stability Indicating RP-UPLC Method for Assay of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Dosage Forms, Am. J. Anal. Chem., 6, 807 (2015); https://doi.org/10.4236/ajac.2015.610077.

S.I. Pasha, M.B. Varanasi and I. Mohammed, Stability Indicating RP-UPLC-PDA Method Development, Validation of Multi Drug Combi-nation of Emtricitabine, Tenofovir Alafenamide and Rilpivirine in Bulk Drug and its Tablet Formulation, Orient. J. Chem., 33, 925 (2017); https://doi.org/10.13005/ojc/330243.

A Novel Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Bictegravir, Emtricitabine and Tenofovir in Pure and Fixed Dose Combination

Article Sidebar

Main Article Content

Abstract

Keywords

Article Details

References

References

Most read articles by the same author(s)