ファーマシューティカ アナリティカ アクタ

概要

Method Development and Validation for estimation of Moxifloxacin HCl in tablet dosage form by RP-HPLC method

P Rama Subbaiah, M V Kumudhavalli, C Saravanan, M Kumar and R Margret Chandira

A rapid, sensitive and specific RP-HPLC method involving UV detection was developed and validated for determination and quantification of Moxifloxacin HCl in tablet dosage form. Chromatography was carried out on a pre-packed Luna C-18, 5μ (250 x 4.6) mm column using filtered and degassed mixture of Buffer: Methanol (55:45) as mobile phase at a flow rate of 1.0 ml/min and effluent was monitored at 293 nm. The pH of the mobile phase was adjusted with acetic acid to 6.3±0.4. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of quantification and limit of detection. The assay was linear over the concentration range of 20 mcg-60 mcg/ 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 99.3 %-100.2 % within precision RSD of 0.58 for Moxifloxacin HCl. The system suitability parameters such as theoretical plates, retention time factor and tailing factor were found to be 7968, 5.855 and 1.207 respectively. The method does require only 10 min as run time for analysis which proves the adoptability of the method for the routine quality control of the drug.