METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CLOSANTEL IN TABLET DOSAGE FORM BY RP-HPLC METHOD

[摘要] A rapid, sensitive and specific RP-HPLC method involving UV detection was developed and validated for determination of closantel in bulk and tablet dosage form. Chromatography was carried out on a phenomenex ODS C-18 column (250 x 4.6 mm), 5 µ particle size using filtered and degassed mixture of water pH adjusted to 3 and acetonitrile in the ratio 10:90 as mobile phase at a flow rate of 1.2 ml/min and effluent was monitored at 333 nm. The method was validated in terms of linearity, precision accuracy and specificity. The assay was linear over the concentration range of 100-500 µg/ml. Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the pre analysed test solution and was found to be 99.53% - 101.06% within precision RSD of 0.00502 for closantel. The system suitability parameters such as theoretical plates, retention time and tailing factor were found to be 10832, 6, and 1.27 respectively. The method does require only 10 mins as run time for analysis, which proves the adoptability of the method for the routine quality control of the drug.

[学科分类] 基础医学

[关键词] Closantel;RP-HPLC;estimation;validation