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DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OFLEVAMISOLE IN PURE AND DOSAGE FORM

A reverse phase isocratic HPLC was developed and validated for the determination of levamisole in pure and tablet dosage forms. Method development was carried out on YMCC18isocratic column, (250 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature), Shimadzu LC-sol 2010 Prominence Liquid Chromatograph. The mobile phase was a mixture of Acetonitrile: Water 80:20 v/v, and the flow rate was set at 0.7 ml/min and UV detection at 217 nm. Validation parameters were evaluated for the method according to the ICH guidelines. In the linearity study, linearity was observed from 10-50 μg/ml with correlation coefficient of 0.9999 and regression coefficient of 0.999. The limit of detection and limit of quantitation for the method were 0.204μg/ml and 0.673μg/ml, respectively. The statistical analysis shows that the method was found to be accurate, reliable, simple and reproducible. The intra and inter assay precisions were satisfactory; the values of relative standard deviations did not exceed 2%. The accuracy of the method was proved; the recovery of levamisole was 98.8% -101.1%. The chromatographic retention time of proposed method was 6.5 min and the assay of content was found to be 98.9%-100.8%. The proposed method was successfully applied for the quantitative determination of levamisole in pure form and could be used for routine analysis with phenomenal accuracy and precisions.