Reversed Phase HPTLC Method Development and Validation for Quantitative Estimation of Valsartan in Drug Substance and Drug Product

AbstractReversed phase high performance thin layer chromatographic method is developed and validated for quantitative estimation of drug substance Valsartan. The CAMAG HPTLC system, operated by software win CATS (Ver.3.2SP2), was used. The mobile phase was comprising of mixture of Methanol: Water (7.0:3.0 V/V). Dried Plates were scanned at 257 nm in absorbance mode. In HPTLC densitogram, Rf was in the range of 0.48 -0.52. Further, developed high performance thin layer chromatographic method validated as per current ICH Q2 guidelines which are for mainly used foe analytical method validation. And accepted globally. The response of Valsartan found in the range of 300 to 900 ng/band. The Limit of detection of Valsartan was 125.2 ng/band while limit of quantification was a 158.0 ng/band. The method is very simple, cost effective, user friendly, non-cumbersome, in line with current guidelines and can be used for quality control purpose in drug substance as well drug product. Keywords HPTLC, Reversed Phase HPTLC, Valsartan, Bulk drug, ICH, analytical method development and validation.