Abstract

DEVELOPMENT OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF REMOGLIFLOZIN AND TENELIGLIPTIN HYDROBROMIDE AND ITS VALIDATION AS PER ICH GUIDELINES

K. V. L. D. Spandana and N. J. P. Subhashini*

ABSTRACT

A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Remogliflozin and Teneligliptin in bulk and dosage forms. The method involves separation on Dionex C18 column (250mm x 4.6mm x5μm particle size). The optimized mobile phase consists of Phosphate buffer (pH 3) and methanol (55:45v/v) with a flow rate of 1ml/min and UV detection at 246nm. Retention time was 2.208min (Remogliflozin), 3.668min (Teneligliptin). Linearity range was 50-150 ug/ml (Remogliflozin), 5-15 ug/ml (Teneligliptin). Accuracy was in the range of 99-101% for both drugs. Precision was 0.19% and 0.48% for Remogliflozin and Teneligliptin. LOD and LOQ are 0.051ug/ml and 0.169ug/ml for Remogliflozin, 0.021ug/ml and 0.070ug/ml for Teneligliptin. The method developed is sensitive, accurate and precise. Retention time and run time were also less and hence the method is economical. Forced degradation studies indicated the suitability of the method for stability studies.

Keywords: Remogliflozin, Teneligliptin, RP-HPLC Method, Simultaneous estimation, Validation as per ICH guidelines, Forced degradation studies.