Development and Validation of a Stability-Indicating HPLC Method for Empagliflozin and Linagliptin in Tablet Dosage Form

Wael Abu Dayyih; Israa Al Ani; Ramadan I. Al-Shdefat; Zainab Zakareia; Sarah Ali Hamid; Ashok K. Shakya

doi:10.14233/ajchem.2021.23019

Issue

Vol. 33 No. 2 (2021): Vol 33 Issue 2

Issue Published : January 15, 2021

This work is licensed under a Creative Commons Attribution 4.0 International License.

Development and Validation of a Stability-Indicating HPLC Method for Empagliflozin and Linagliptin in Tablet Dosage Form

https://doi.org/10.14233/ajchem.2021.23019

Wael Abu Dayyih

Faculty of Pharmacy and Medical Sciences, University of Petra, Amman, Jordan

Israa Al Ani

Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, Jordan

Ramadan I. Al-Shdefat

Faculty of Pharmacy, Jadara University, Irbid, Jordan

Zainab Zakareia

Faculty of Pharmacy and Medical Sciences, University of Petra, Amman, Jordan

Sarah Ali Hamid

Faculty of Pharmacy, Uruk University, Baghdad, Iraq

Ashok K. Shakya

Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, Jordan ; Pharmacological and Diagnostic Research Center, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, Jordan

Corresponding Author(s) : Zainab Zakareia

Asian Journal of Chemistry, Vol. 33 No. 2 (2021): Vol 33 Issue 2
Article Published : January 15, 2021

Abstract

A simple, stability indicating high performance liquid chromatographical (HPLC) method was developed and validated for the estimation of empagliflozin and linagliptin in combined dosage forms. Chromatographical separation was optimized by isocratic HPLC using C-18 column [BDS 250 mm × 4.6 mm, 5 μm] utilizing a mobile phase consisting a mixuture of 0.1% orthophosphoric acid and acetonitrile (60:40 v/v) running at a rate of 1 mL/min and monitoring effluents at 230 nm. The retention time of empagliflozin and linagliptin was 2.05 min and 4.10 min, respectively. Correlation coefficient (r²) was 0.999 for both empagliflozin and linagliptin. The precision of method for the analysis of empagliflozin and linagliptin were 0.33 and 0.22, respectively. The accuracy of method (as recovery) was 100.96 to 101.48% for empagliflozin and 100.09 to101.13% for linagliptin. The results indicate the present method is accurate, precision and rugged as these results are within the specified limits. Therefore, the validated economical methodology can be applied for forced degradation study of empagliflozin and linagliptin in solid dosage forms.

Keywords

Empagliflozin Linagliptin Optimization Validation Stress study Stability. HPLC method

Abu Dayyih, W., Al Ani, I., I. Al-Shdefat, R., Zakareia, Z., Ali Hamid, S., & K. Shakya, A. (2021). Development and Validation of a Stability-Indicating HPLC Method for Empagliflozin and Linagliptin in Tablet Dosage Form. Asian Journal of Chemistry, 33(2), 484–488. https://doi.org/10.14233/ajchem.2021.23019

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References

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References

Indian Pharmacopoeia, Government of India Ministry of Health and Family Welfare, The Controller of Publication, Delhi, vol. 2, p. 340, 1657-1660 (2010).

J.G. Hardman, L.E. Limbird and A.G. Gilman Goodman and Gilman’s The Pharmacological Basis of Therapeutics, McGraw Hill Publication: New York, edn 10, pp. 1686-1687, 1700 (2001).

H.P. Rang, M.M. Dale, J.M. Ritter and P.K. Moore, Pharmacology, Elsevier Publication: Churchill Livingstone, Edinburgh, edn 7, p. 372 (2007).

National Center for Biotechnology Information, PubChem Compound Database;CID=10096344, https://pubchem.ncbi.nlm.nih.gov/compound/10096344 (accessed Sept. 27, 2016).

National Center for Biotechnology Information, PubChem Compound Database;CID=11949646, https://pubchem.ncbi.nlm.nih.gov/compound/11949646 (accessed Sept. 27, 2016).

Shyamala, M. Soumika, E. Sangeetha and L. Mahender, Int. J. Adv. Pharm. Sci., 7, 3040 (2016).

N. Padmaja and G. Veerabhadram, Int. J. Pharm. Sci. Res., 7, 724 (2016).

C. Veeresham, P. Vemula, D. Dodda, U. Balekari and S. Panga, J. Adv. Pharm. Technol. Res., 6, 25 (2015); https://doi.org/10.4103/2231-4040.150368

R.I. El-Bagary, E.F. Elkady and B.M. Ayoub, Int. J. Biomed. Sci., 9, 41 (2013).

R.H. Pandya, G. Rathod and D.G. Maheswari, Pharmacophore, 5, 202 (2014).

B.R.C. Shekar Reddy, N.V. Bhaskar and K. Saraswathi, Pharm. Sin., 5, 131 (2014).

W.A. Dayyih and R. Al-Shdefat, J. Pharm. Sci. Res., 11, 2934 (2019).

S.A. Sarah, L.N. Tamimi and W. Abu Dayyih, J. Glob. Trends Pharm. Sci., 9, 5657 (2018).

W.A. Dayyih, Z. Zakarya, A.A. Dayyih and I.H. Al-Ani, Der Pharm. Chem., 10, 68 (2018).

W. Abu Dayyih, M. Hamad, E. Mallah, A.A. Dayyih and R. Awad, Int. J. Pharm. Sci. Res., 9, 2965 (2018).

J. Srivani, B. Umamahesh and C. Veeresham, Int. J. Pharm. Pharm. Sci., 8, 112 (2015).

K.Y. Kavitha, G. Geetha, R. Hariprasad, M. Kaviarasu and R. Venkatnarayanan, J. Chem. Pharm. Res., 5, 230 (2013).

S.S. Mourad, E.I. El-Kimary, M.A. Barary and D.A. Hamdy, Bioanalysis, 11, 1321 (2019); https://doi.org/10.4155/bio-2018-0097

B.M. Ayoub, RSC Adv., 5, 95703 (2015); https://doi.org/10.1039/C5RA17231D

ICH Guidelines for the Stability of New Drug Substances and Products, Q1A(R2) ICH, Geneva, pp. 1-13 (2005).

ICH Guidelines for Validation of Analytical Procedures: Text and Methodology, Q2(R1) ICH, Geneva, pp. 1-14 (2005).

Issue

Vol. 33 No. 2 (2021): Vol 33 Issue 2

Development and Validation of a Stability-Indicating HPLC Method for Empagliflozin and Linagliptin in Tablet Dosage Form

Corresponding Author(s) : Zainab Zakareia

Abstract

Keywords

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