Abstract

DEVELOPMENT AND VALIDATION OF NOVEL RP- HPLC METHOD FOR RELATED SUBSTANCES IN CHLORTHALIDONE AND FIMASARTAN FORMULATIONS

Kritika Rai and Dr. Nutan Rao*

Abstract

The objective of the present work was to develop and validate a novel stability-indicating method for the simultaneous estimation of chlorthalidone and fimasartan potassium trihydrate pharmaceutical tablet dosage form by reversed-phase high-performance liquid chromatography (RP- HPLC). As of now no RP- HPLC method has been reported for this combination. The method was developed using Shimadzu LC Prominence-i 2030 model with chromeleone software and the separation was done on Zodiac C18 (250*4.6mm), 5μ column with a flow rate of 1.5 ml/min and run time of 50 min. The injection volume was 20 μl and mobile phase consisted of buffer pH 3.0 and 100% methanol in the ratio of 50:50 and 230 nm was used as a detection wavelength. The retention time was found to be 12.342 min and 32.727 min for chlorthalidone and fimasartan potassium trihydrate and for known impurity Chlorthalidone Rel. Comp. A the retention time is 20.325. The calibration curve was found to be linear and r values were 0.9996 and 0.9998 for chlorthalidone and fimasartan potassium trihydrate, respectively. The wide linearity range, precision, sensitivity, accuracy, short retention time, and simple mobile phase showed that the following method is suitable for routine quantification of impurities in chlorthalidone and fimasartan potassium trihydrate formulations in pharmaceutical dosage forms with high precision and accuracy.

Keywords: Fimasartan potassium trihydrate, Chlorthalidone, RP-HPLC, validation.