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Simultaneous HPLC Method Development and Validation for Estimation of Lamivudine, Abacavir and Dolutegravir in Combined Dosage Form with their Stability Studies
Corresponding Author(s) : Narottam Pal
Asian Journal of Chemistry,
Vol. 28 No. 2 (2016): Vol 28 Issue 2
Abstract
A simple and rapid high performance liquid chromatographic method was developed and validated for simultaneous estimation of abacavir, lamivudine and dolutegravir in their tablet dosage form. The method was established using non polar column-Kromasil 250 mm × 4.5 mm, 5 μm, mobile phase as buffer:acetonitrile (65:35) at a flow rate of 1 mL/min with isocratic elution, injecting 10 μL sample into the chromatographic system. The eluted compounds were detected by using PDA Detector at detection wavelength of 257 nm and temperature was maintained at 30 °C. Retention times for the three compounds were found to be 2.250 min, 2.734 min and 9.633 min for lamivudine, abacavir and dolutegravir, respectively. The linearity range was 15 to 90 ppm, 30 to 180 ppm and 2.5 to 15 ppm with values of LOD found to be 0.08 μg, 0.06 μg, 0.03 μg and LOQ were found to be 0.2 μg, 0.19 μg and 0.10 μg for lamivudine abacavir and dolutegravir, respectively which were linear enough showing correlation coefficient 0.999 in all the cases. The present method was specific, sensitive, reproducible, precise, rapid and simple.
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- webmd.com/a-to-z-guides/bacterial-and-viral-infections.
- www.wikipedia.org/wiki/Abacavir;www.wikipedia.org/wiki/Lamivudine;www.wikipedia.org/wiki/ Dolutegravir
- W. Lund, The Pharmaceutical Codex, The Pharmaceutical Press, London, edn 12, pp. 277-283, (1994).
- T. Sudha, J. Saminathan, K. Anusha, M. Keerthi, Y. Bhargavi and V. Ganesan, J. Chem. Pharm. Res., 2, 45 (2010).
- S.R. Srikakolapu, I. Khan, S.D. Gotteti, M.K. Jangala, T. Kolla and K. Gondala, Arch. Appl. Sci. Res., 2, 23 (2010).
- S.M. Ferrer, P. Modamio, C.F. Lastra and E.L. Mariño, Biomed. Chromatogr., 18, 862 (2004); doi:10.1002/bmc.406.
- R. Venkatamahesh and D. Dhachinamoorthi, Int. J. PharmTech Res., 3, 356 (2011).
- C. Bennetto-Hood, G. Tabolt, P. Savina and E.P. Acosta, J. Chromatogr. B, 945-946, 225 (2014); doi:10.1016/j.jchromb.2013.11.054.
- B. Fan and J.T. Stewart, J. Pharm. Biomed. Anal., 28, 903 (2002); doi:10.1016/S0731-7085(01)00708-7.
- D.K. Mandloi, P.K. Tyagi, V.K. Rai, S. Dey, R.K Ashada and P. Mohanraj, J. Chem. Pharm. Res., 1, 286 (2009).
- Ch. Balasekarreddy, B.Z. Awen, Ch. Babu Rao, N. Sreekanth and P. Ramalingam, Pharmanest, 1, 22 (2010).
- T. Raja and A.L. Rao Int. J. PharmTech Res., 3, 852 (2011).
- L.R. Snyder, J.J. Kirkland and J.L. Glajch,Practical HPLC Method Development, Wiley,edn 2 (1997).
- ICH Harmonised Tripartite Guideline; Validation of Analytical Procedures: Text and Methodology-Q2(R1) (1996).
- S. Yoshioka and V. Stella, Stability for Drugs and Dosage Forms, Kluwer Academic Plenum Publishers, New York, pp. 11-12 (2000).
- S. Budavari, The Merck Index, Merck & Co., Whitehouse Station, NJ, edn 13 (2001).
References
webmd.com/a-to-z-guides/bacterial-and-viral-infections.
www.wikipedia.org/wiki/Abacavir;www.wikipedia.org/wiki/Lamivudine;www.wikipedia.org/wiki/ Dolutegravir
W. Lund, The Pharmaceutical Codex, The Pharmaceutical Press, London, edn 12, pp. 277-283, (1994).
T. Sudha, J. Saminathan, K. Anusha, M. Keerthi, Y. Bhargavi and V. Ganesan, J. Chem. Pharm. Res., 2, 45 (2010).
S.R. Srikakolapu, I. Khan, S.D. Gotteti, M.K. Jangala, T. Kolla and K. Gondala, Arch. Appl. Sci. Res., 2, 23 (2010).
S.M. Ferrer, P. Modamio, C.F. Lastra and E.L. Mariño, Biomed. Chromatogr., 18, 862 (2004); doi:10.1002/bmc.406.
R. Venkatamahesh and D. Dhachinamoorthi, Int. J. PharmTech Res., 3, 356 (2011).
C. Bennetto-Hood, G. Tabolt, P. Savina and E.P. Acosta, J. Chromatogr. B, 945-946, 225 (2014); doi:10.1016/j.jchromb.2013.11.054.
B. Fan and J.T. Stewart, J. Pharm. Biomed. Anal., 28, 903 (2002); doi:10.1016/S0731-7085(01)00708-7.
D.K. Mandloi, P.K. Tyagi, V.K. Rai, S. Dey, R.K Ashada and P. Mohanraj, J. Chem. Pharm. Res., 1, 286 (2009).
Ch. Balasekarreddy, B.Z. Awen, Ch. Babu Rao, N. Sreekanth and P. Ramalingam, Pharmanest, 1, 22 (2010).
T. Raja and A.L. Rao Int. J. PharmTech Res., 3, 852 (2011).
L.R. Snyder, J.J. Kirkland and J.L. Glajch,Practical HPLC Method Development, Wiley,edn 2 (1997).
ICH Harmonised Tripartite Guideline; Validation of Analytical Procedures: Text and Methodology-Q2(R1) (1996).
S. Yoshioka and V. Stella, Stability for Drugs and Dosage Forms, Kluwer Academic Plenum Publishers, New York, pp. 11-12 (2000).
S. Budavari, The Merck Index, Merck & Co., Whitehouse Station, NJ, edn 13 (2001).