Abstract

UV METHOD DEVELOPMENT AND VALIDATION OF EMPAGLIFLOZIN AND LINAGLIPTIN

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

ABSTRACT

The research suggest simple, sensitive, precise, accurate and robust UV-Spectrophotometric method for simultaneous estimation of Empagliflozin and Linagliptin in its pure and tablet dosage form. The method involves Simultaneous Equation Method, which is based on measurement of absorption at 224nm and 238nm for Empagliflozin and Linagliptin respectively. Linearity was observed in the concentration range of 6-12µg/ml for both the drugs and found regression coefficient 0.99. The accuracy and precision were found within the acceptable range. The low limit of detection and limit of quantification values prove the sensitivity of the proposed method. The developed method was validated as per ICH Q2 R1 guidelines found to be satisfactory. The proposed method was found to be simple, sensitive, specific, precise, accurate and robust. Hence the proposed method can be successfully applied for the routine analysis of Empagliflozin and Linagliptin in its pure and tablet dosage form.

Keywords: Empagliflozin, Lnagliptin, Simultaneous equation method.