Abstract

COMPARATIVE STUDY OF TWO DIFFERENT MARKETED PREPARATION (TABLETS) CONTAINING EMPAGLIFLOZIN & LINAGLIPTIN AND DEVELOPING NOVEL METHOD FOR SIMULTANEOUS ESTIMATION OF EMPAGLIFLOZIN AND LINAGLIPTIN USING UV VISIBLE SPECTROPHOTOMETER

Pravin Cholke*, Yogita Temak, Chandrakala Pharate, Priya Machale, Monika Jagtap Rutuja Machale, Komal Handgar, Vidya Ghadge and Kajal Shelar

ABSTRACT

A simple, precise, accurate and economic simultaneous UV spectrophotometric method has been developed for the estimation of Empagliflozin & Linagliptin in combination in bulk and tablet. The estimation was based upon measurement of absorbance at absorbance maxima of (λmax) 233nm for Empagliflozin (API) and 277 nm for Linagliptin (API) in Ethanol: Distilled Water (1:1 ratio) as a solvent respectively in bulk mixture and tablet. The Beer Lambert’s law obeyed in the concentration range 5-25 μg/ml, 10-50 μg/ml for Empagliflozin & Linagliptin respectively. The estimation of bulk mixture and tablet was carried out by simultaneous equation, Q-analysis and area under curve method for estimation of Empagliflozin & Linagliptin. Method was validated with respect to specificity, linearity, range, accuracy, precision, Limit Of Detection, Limit Of Quantitation. Validation was performed as per ICH guidelines the results were found out to be for Empagliflozin & Linagliptin. (As per Label Claim). Comparative Study was done using Two Different Marketed Preparation (Tablet) Containing Empagliflozin & Linagliptin. (GLYXAMBI (10/5) TABLET: BOEHRINGER INGELHEIM LTD, AJADUO (10/5)TABLET: LUPIN LTD)

Keywords: Empagliflozin, Linagliptin, Comparative Study , Simultaneous Estimation.