Quantitative analysis of valsartan in tablets formulations by High Performance Thin-Layer Chromatography.

ABSTRACT

A new, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) method has been established for quantitative analysis of valsartan in tablet formulations. Standard and sample solutions of valsartan were applied to precoated silica gel G 60 F254 HPTLC plates and the plates were developed with chloroform acetonitrile toluene glacial acetic acid, in the ratio 1810.1 (v/v) (v/v), as mobile phase. UV detection was performed at 254 nm. The retention factors of valsartan was 0.65. The calibration plot for Valsartan standard was linear with r =0.9999, slope = 5.328 and intercept=356.9. The limit of detection and limit of quantitation of Valsartan were found to be 5and 16 ng per spot respectively. The percentage recovery was found to be 99.37% for Valsartan. The method showed good repeatability and recovery with relative standard deviation less than 2. Method was validated in accordance with the requirements of ICH guidelines and was shown to be suitable for purpose. The method is selective and specific can be used for determination of the routine analysis of valsartan in tablets. Tablet excipients did not interfere with the chromatography.