HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE FROM BULK AND IT'S ORAL FORMULATION

A simple and selective high performance thin layer chromatographic (HPTLC) method was developed and validated for the estimation of ziprasidone hydrochloride monohydrate (ZHM) from its marketed formulation and oral formulation. The CAMAG HPTLC system, operated with software winCATS (ver.1.4.1.8) was used for proposed analytical work. Planar chromatographic development was carried out with the help of silica gel 60 F254 precoated aluminium TLC plates. Sample application was employed using Linomat 5 applicator. The optimized mobile phase was composed of toluene: glacial acetic acid: methanol (6: 0.3: 3 V/V/V). The detection of spots was carried out densitometrically using a UV detector at 317nm in absorbance mode. In HPTLC densitogram well defined peak was obtained for ZHM with starting position at 59 hRf, max position at 63 hRf and end position at 65 hRf. The optimum hRf value for ZHM was found to be 63. Performance characteristics of HPTLC method for estimation of ZHM in bulk drug and its marketed dosage form were statistically validated as per recommendations of ICH guidelines of analytical method validation. The HPTLC method was found to be linear across the range 20-140 ng/band. The LOD and LOQ values were found to be 13.573 and 41.130 ng/band, respectively. The method was found to be accurate, precise, robust and economical for the analysis of ZHM from bulk drug and its formulation. The proposed analytical HPTLC method can be used for routine quality-control analysis of ZHM.