Development and Validation of HPTLC Method for Estimation of Cyamemazine Tartrate and its Formulation

Abstract

A simple, precise, accurate high performance thin layer chromatographic (HPTLC) method has been developed for estimation of cyamemazine tartrate from a bulk drug and combined dosage form. The separation of drugs was carried out on Merck HPTLC aluminium sheets of Silica gel 60 F254 TLC plates as stationary phase and the chromatogram was developed using Benzene: Methanol (4.2:0.8v/v) as the mobile phase. Cyamemazine tartrate showed Rf values 0.45, when scanned densitometrically at 260 nm using Camag TLC Scanner. The described method was linear over a concentration range of 200 ng/spot to 1200 ng/spot for cyamemazine tartrate. Results of analysis were validated according to International Conference on Harmonization ICH Q2B guidelines statistically, and by recovery studies. The limit of detection (LOD) and limit of quantification (LOQ) for cyamemazine tartrate was found to be 28.47 ng/spot 86.29 ng/spot respectively. The results of the study showed that the proposed HPTLC method is simple, rapid, precise and accurate, which is useful for the routine determination of cyamemazine tartrate bulk drug and in its pharmaceutical dosage form.