RP-HPLC Based Stability Indicating Assay of Evogliptin and Metformin: Development and Validation of the Analytical Method

DOI:

https://doi.org/10.37285/ijpsn.2023.16.2.6

Authors

  • Surya Prakash Gupta Rajiv Gandhi Institute of Pharmacy, AKS University, Satna (MP)-India
  • Sachin Singh Rajiv Gandhi Institute of Pharmacy, AKS University, Satna (MP)-India

Abstract

Background: Several new fixed dose combinations have been recently approved by the Food and Drug Administration for treatment of disease conditions. All these combinations require specific, accurate and precise analytical methods for estimation for simultaneous estimation.

Methods: A new RP-HPLC method was developed for the stability indication of evogliptin and metformin in tablets and it was validated as per ICH guidelines. The chromatogram for was found to be satisfactory on symmetry C-18 (4.6×150mm, 5µ Kromasil column) using phosphate buffer (pH 4.5) and acetonitrile in the ratio of 30:70 v/v at a flow rate of 0.8 ml/min.

Results: The retention time of evogliptin and metformin were found to be 7.03 min and 9.50 min respectively. The system suitability parameters proved that the proposed method was found to be suitable for stability indication of evogliptin and metformin. Tailing factor for the peak was found to be 1.003 and 1.258. The method was found to be linear in the range of 10-50µg/ml for both the drugs. The precision of the method was good and the recovery of drugs is well within the acceptance limits of 80-120%. The LOD and LOQ was found to be 0.003 µg/ml, 0.12 µg/ml and for evogliptin and 0.09 µg/ml and 0.03 µg/ml for metformin.

Conclusion: A simple, accurate and precise method tor routine analysis of the combination of evogliptin and metformin was developed and was applicable for the stability analysis of the combination.

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Keywords:

Evogliptin, Metformin, RP-HPL, stability, validation, analytical method

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Published

2023-05-01

How to Cite

1.
Gupta SP, Singh S. RP-HPLC Based Stability Indicating Assay of Evogliptin and Metformin: Development and Validation of the Analytical Method. Scopus Indexed [Internet]. 2023 May 1 [cited 2024 Dec. 11];16(2):6438-44. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/3647

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Section

Research Articles

References

Tan X, Hu J. Evogliptin: a new dipeptidyl peptidase inhibitor for the treatment of type 2 diabetes. Expert Opinion in Pharmacotherapeutics. 2016; 17(9): 1285-1293

Powers AC, D’Alessio D. Endocrine Pancreas and Pharmacotherapy of Diabetes Mellitus and Hypoglycemia. In Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 13th Ed, McGraw Hill Education, New York, 2018. pp. 863-886

The Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare The Indian Pharmacopeia commission, Ghaziabad, Vol. 1, 2007, pp 244

British Pharmacopoeia, The department of Health, Social Service and public Safety, The British Pharmacopoeia Commission, 2003; 4: 1219-1220.

Nikam N, Maru A, Jadhav A, Malpure P. Analytical Method Development and Validation of Metformin Hydrochloride by using RPHPLC with ICH Guidelines. International Journal of Trends in Scientific Research and Development. 2019; 3(3): 415-419.

Chadalawada P, Velupla D, Challa A, Puvvala S, Khan I. RP-HPLC Analytical Method Development and Validation of Metformin Hydrochloride Tablets Assay. International Journal of Pharmaceutical and Biological Sciences. 2019; 9(3): 505-519.

Rao BS, Dubey SS, Rao KN, Kiran BV. Development and Validation of A Reverse Phase HPLC Method for the Determination of Metformin HCl in Pharmaceutical Dosage Forms. Chemistry: An Asian Journal. 2012; 24(12): 5460-5462.

Madhukar A, Prince A, Vijay R, Sanjeeva Y, Jagadeeshwar K, Raghupratap D. Simple and sensitive analytical method development and validation of metformin hydrochloride by RP-HPLC. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 3(3): 117-120.

Agrawal YP, Agrawal MY, Jadhav SB, Shinde RJ. Development and Validation of Novel UV Spectrophotometric Method for the Determination of Evogliptin Tartarate in Pharmaceutical Dosage Form. Indian Journal of Pharmaceutical Education and Research. 2020; 54(4): 1174-1179.

Vetapalem R, Yejella RP, Atmakuri LR. Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Metformin. Turkish Journal of Pharmaceutical Sciences. 2020; 17(2): 141-147.

Patel A, Patel R, Yadav P. Development and Validation of RP- HPLC Method for estimation of Evogliptin in Pharmaceutical Dosage Form. International Journal of Pharmaceutical Research and Applications. 2021; 6(2): 775-781.

Dolas J, Jawarkar S, Rode RJ. Novel method development, validation, and stability indicating assay method for evogliptin tartrate in pharmaceutical dosage form by RP-HPLC. Journal of Emerging Technologies and Innovative Research. 2022; 9(2): b327-b345.

Biswas P, Jain P, Parkhe G, Mishra B. Validated HPLC method for the estimation of Aspirin and Omeprazole in dosage form. Journal of Pharmacology and Biomedicine. 2018; 2(3): 171-180.

The Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare The Indian Pharmacopeia commission, Ghaziabad, 2018; 7: 2544-2548.

Patel A, Soni P, Yadav N, Omray LK. New cost-effective RP-HPLC method development and evaluation for quantitative estimation of Pitavastatin in pharmaceutical formulation. Journal of Pharmacology and Biomedicine. 2018; 2(3): 181-188

Kumar A, Mishra R, Mishra B. Validation of RP-HPLC based stability indicating assay for promethazine hydrochloride. International Journal of Pharmacy Practice and Pharmaceutical Sciences. 2020; 2(1): 1-7