抽象的

Development and validation of stability-indicating highperformance thin-layer formulation chromatography method for estimation of cilostazole in bulk and in pharmaceutical formulation

Mujeeb G.Khan, P.S.Jain, S.J.Surana

Asimple, selective, precise and Stability-indicatingHigh-performance thinlayer chromatographic method for analysis of Cilostazole both in a bulk and in pharmaceutical formulation has been developed and validated. The method employed, HPTLC aluminium plates precoated with silica gel as the stationary phase. The solvent system consisted of toluene: ethyl acetate: methanol: ammonia (3.5:2:0.8:0.3 v/v/v). The system was found to give compact spot for Cilostazole (Rf value of 0.52±0.02). Densitometric analysis of Cilostazole was carried out in the absorbance mode at 258 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.992±0.0001 with respect to peak area in the concentration range 300 - 1800 ng per spot. The mean value ± S.D. of slope and intercept were 4.6809 ± 0.005 and 2284.4 ± 4.20 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantificationwere 15.69 and 45.07 ng per spot, respectively. Cilostazole was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic and basic conditions. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved fromthe pure drug with significantly different Rf value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of Cilostazole in bulk drug and pharmaceutical formulation.