Abstract

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF VALSARTAN AND NIFEDIPINE IN SYNTHETIC MIXTURE

Patel Chiragkumar B.* and Patel Satish A.

Abstract

A simple, precise, sensitive, rapid high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of the Valsartan and Nifedipine in synthetic mixture. The stationary phase used was precoated silica gel 60F254 plate. The mobile phase used was a mixture of toluene: acetonitrile: formic acid (8:2:0.2, v/v/v). The detection of spots was carried out densitometrically using a UV detector at 227 nm in absorbance mode. This system was found to give compact spots for Valsartan with Rf value of 0.25. and Nifedipine and with Rf value of 0.49. The method was validated according to ICH guidelines in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 300 to 2100 ng/spot for both the drugs with significantly high value of correlation coefficient (r2 > 0.99). The limits of detection and limits of quantitation were found to be 16.86 and 51.17 ng/spot respectively for Valsartan and 18.18 and 55.10 ng/spot respectively for Nifedipine. All the validation parameters were found to be within acceptable limits. The method was found to be rapid, cost effective, accurate and precise therefore be utilized for the routine analysis of both the drugs in synthetic mixture. The proposed method can be used in the quality control of both the drugs in synthetic mixture.

Keywords: Valsartan, Nifedipine, HPTLC, Synthetic mixture, Validation.