ファーマシューティカ アナリティカ アクタ

概要

Development and Validation of a Stability Indicating UPLC Method for Determination of Moxifloxacin Hydrochloride in Pharmaceutical Formulations

G. Naveen Kumar Reddy, V.V.S.Rajendra Prasad, Nigam Jyoti Maiti, Diptimayee Nayak and Prashant Kumar Maharana

Simple, rapid, sensitive, accurate, robust & rugged stability indicating analytical method for determination of Moxifloxacin HCl in pharmaceutical formulations is developed and validated by using UPLC & applied the developed and validated method for determining the assay of Moxifloxacin HCl in tablets (Avelox®), as there is no official monograph & no analytical method by UPLC. Chromatography was performed with mobile phase containing potassium dihydrogen ortho phosphate (adjusted to pH 1.8 with orthophosphoric acid), Methanol & acetonitrile in the ratio of 60:20:20, with a flow rate of 0.3mL/min, C-18 column & UV detection at 296nm.The method was validated for linearity, accuracy, ruggedness, robustness, precision & bench top stability of sample & standard solution. Moxifloxacin tablets were subjected to different stress conditions like acid, alkali, peroxide, thermal, water & UV studies and checked for its specificity, degradation & stability. The developed method was very rapid with a run time of 3 min, accurate, robust, rugged and stable.