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Development and Validation of RP-HPLC Method for Determining Impurity Profiling Fortolperisone Hydrochloride in Tablet Dosage Form

Nandini R. Pai and Seema S. Sawant

A simple, rapid, sensitive, accurate, precise and reproducible high performance liquid chromatographic method was developed to estimate impurity1,2 profile for Tolperisone hydrochloride3 in tablet4,5 dosage2 form. The HPLC2 analysis used a reversed phase Oyster ODS (300 x 4.6 mm, 5 μm) column and a mobile phase constituted of buffer and acetonitrile (45 : 55 % v/v). The buffer was composed of 95.0 mL 0.1 M citric acid, and 5.0 mL of 0.2 M sodium dihydrogen phosphate in 1000 mL of water, mix and adjusted the pH to 2.5 with orthophosphoric acid and with addition of 10 g of sodium lauryl sulfate. The wavelength of the detection was 260 nm. The validation6,7 data showed that the method is sensitive, specific and reproducible for the impurity determination of Tolperisone hydrochloride in the tablet dosage form. The method was linear from 0.5 μg/mL to 3.5 μg/mL for Tolperisone hydrochloride, impurity E2,3 (vinyl ketone) and 2-methylhydroxy impurity and from 0.2 μg/mL to 1.4 μg/mL for impurity 4-MMP.2,3 The accuracy of the method was found to be 99.39% for 4-MMP impurity, 99.38% for impurity E (vinyl ketone) and 100.22% for 2-methylhydroxy impurity.8,9 Inter and intraday assay relative standard deviation (RSD) was found 0.32% for 4-MMP impurity, 0.32% for impurity E (vinyl ketone) and 0.47% for 2-methylhydroxy impurity in tablet dosage form. The proposed method provided an accurate and precise analysis of 4-MMP impurity, impurity E (vinyl ketone) and 2-methylhydroxy impurity for Tolperisonehydrochloride in pharmaceutical dosage form.