Development And Validation of Analytical Methods for The Simultaneous Estimation of Empagliflozin and Linagliptin In Bulk And In Pharmaceutical Dosage Form

Authors

Dr. Kamble P.A, Miss. Sawant Supriya, Miss. Mazalkar Komal, Mr. Mohd Ameen Mahmood, Miss Payal Indurkar

Abstract

Simple, precise and economical UV Spectrophotometric methods have been developed for the simultaneous estimation of Empagliflozin and Linagliptin in bulk and pharmaceutical dosage forms. The simultaneous equation (Vierodt’s Method), which is based on measurement of absorption at 233nm and 277nm i.e. λmax of Empagliflozin and Linagliptin respectively. Linearity was observed in the concentration range of 5-15µg/ml for Empagliflozin and 2-6µg/ml for Linagliptin. The accuracy of methods was assessed by recovery studies and was found to be within range of 98-101% for both Empagliflozin and Linagliptin. The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The method can be employed for estimation of pharmaceutical formulations with no interference from any other excipients and diluents. The results were validated statistically as per ICH Q2 R1 guidelines and were found to be satisfactory.

Keywords

Diabetes, Empagliflozin, Linagliptin, analytical validation

Development And Validation of Analytical Methods for The Simultaneous Estimation of Empagliflozin and Linagliptin In Bulk And In Pharmaceutical Dosage Form. Dr. Kamble P.A, Miss. Sawant Supriya, Miss. Mazalkar Komal, Mr. Mohd Ameen Mahmood, Miss Payal Indurkar. 2024. IJIRCT, Volume 10, Issue 3. Pages 1-7. https://www.ijirct.org/viewPaper.php?paperId=2406035