米国先進ドラッグデリバリージャーナル オープンアクセス

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Method Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ofloxacin and Ketorolac Tromethamine in Bulk and its Pharmaceutical Formulations

Brahma Reddy Gade, Sita Ram Bandhakavi and Ganji Ramanaiah

A new rapid, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of Ofloxacin and Ketorolac tromethamine simultaneously in combined dosage form. The two components Ofloxacin and Ketorolac tromethamine were well resolved on an isocratic method, C8 column, utilizing a mobile phase composition of acetonitrile: methanol: a mixed buffer of 0.02M Potassium dihydrogen phosphate and sodium dihydrogen phosphate buffer (20:20:60), v/v, pH 4.8) at a flow rate of 1.0 mL/min with UV detection at 295 nm. The retention time of Ofloxacin and Ketorolac tromethamine were 3.2 min and 4.2 min respectively. The developed method was validated for specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness as per ICH guidelines. Linearity for Ofloxacin and Ketorolac tromethamine were found in the range of 20-60 µg/ml and 12-36 µg/ml, respectively. The percentage recoveries for Ofloxacin and Ketorolac tromethamine ranged from 97-99 % and 96-100 %, respectively. The proposed method could be used for routine analysis of Ofloxacin and Ketorolac tromethamine in their combined dosage forms.

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