Abstract

DEVELOPMENT AND VALIDATION OF TWO UVSPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF EMPAGLIFLOZIN AND LINAGLIPTIN IN ITS PURE AND PHARMACEUTICAL DOSAGE FORM

Priyanka K.*, K. Vinod Kumar, T. Snehalatha, Md. Abdul Sufiyan, N. Kavya, K. Akhila

Abstract

The proposed research suggests two simple, sensitive, precise and accurate UV-Spectrophotometric methods for simultaneous estimation of Empagliflozin and Linagliptin in its pure and tablet dosageform. Method A involves Simultaneous Equation Method, which is based on measurement of absorption at 224nm and 238nm for Empagliflozin and Linagliptin respectively. Method B is the Absorption Ratio Method which is based on measurement of absorption at wavelength of 224nm and 228nm i.e. λmax of Empafliflozin and iso-absorptive point of Empagliflozin and Linagliptin respectively. Linearity was observed in the concentration range of 6-12μg/ml for both the drugs in both the methods. The accuracy of two methods were found to be within the range of 99.5-101.6% for both Empagliflozin and Linagliptin. The precision of Empagliflozin and Linagliptin in both methods are within the limits. The low limit of detection and limit of quantification values prove the sensitivity of the proposed methods. The developed methods were validated as per ICH Q2 R1 guidelines and were found to be satisfactory. The proposed two methods were found to be simple, sensitive, specific, precise and accurate. These two methods can be successfully applied for the routine analysis of Empagliflozin and Linagliptin in its pure and tablet dosage form.

Keywords: Empagliflozin, Linagliptin, Simultaneous equation method and Q-Absorbance Ratio Method.