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DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR QUANTITATIVE ESTIMATION OF PALIPERIDONE

Journal: Indian Drugs (Vol.55, No. 09)

Publication Date:

Authors : ; ; ;

Page : 34-40

Keywords : ;

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Abstract

A planar chromatography (HPTLC) method has been developed and validated for quantitative estimation of the atypical antipsychotic drug paliperidone, which is weakly basic and poorly water soluble. The Camag HPTLC system, operated by software winCATS (ver.1.4.1.8), was used. Sample application was facilitated by Linomat 5 applicator. After sample application, plates were subjected to ascending development in twin trough chamber of size 10 cm x10 cm, using about 10 mL of mobile phase. The optimized mobile phase was composed of ethyl acetate:chloroform:toulene:methanol (2.5:2.5:2.5:2.5 v/v/v/v). In post development, the plates were air dried and then scanned densitometrically using a UV detector at 278 nm in absorbance mode. In HPTLC densitogram, well defined peak was obtained for paliperidone with starting position at 0.27 Rf, max position at 0.31 Rf and end position at 0.34 Rf. The optimal Rf value for paliperidone was found to be 0.31. Performance characteristics of proposed and newly developed HPTLC method were statistically validated as per recommendations of ICH guidelines of analytical method validation. The HPTLC method was found to be linear across the range from 20 to 140 ng/band. The LOD and LOQ values were found to be 1.288 and 3.905ng/band, respectively. The method was found to be accurate, precise, robust and economical for the determination of paliperidone from bulk and its extended release tablet formulation.

Last modified: 2018-10-04 15:38:40