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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF MOXIFLOXACIN AND BETAMETHASONE SODIUM PHOSPHATE IN THEIR COMBINED DOSAGE FORM

Patel Grishma H.*, Parikh Urvish, Pradhan Prasanna ku., Shah Shreya R., and Upadhyay Umesh U.

ABSTRACT

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for Moxifloxacin(MOXI) and Betamethasone Sodium Phosphate(BETA) for the simultaneous estimation of Moxifloxacin and Betamethasone Sodium Phosphate in their combined dosage forms. BDS Hypersil C-18 column (250mm×4.6mm, id) 5 μm particle size was used as stationary phase. The mobile phase used was Phosphate buffer: Methanol (65:35v/v) at Ph4.0 adjusted with Orthophosphoric acid. A flow rate of 1.0 ml/min was delivered. UV detection was set at 274 nm. Retention time for MOXI and BETA was found to be 4.5 min and 7.4 min respectively. The linearity was observed over the range of 25-75mcg/ml and 5-15mcg/ml for MOXI and BETA respectively. LOD was found to be 1.73mcg/ml and 0.50mcg/ml for MOXI and BETA respectively, whereas LOQ was found to be 5.26mcg/ml and 1.54mcg/ml. The correlation co-efficient found to be 0.999 and 0.999 for MOXI and BETA respectively. Moreover, the %RSD for repeatability, Inter and intra-day precision was found to be less than 2% which reveals method is precise. The %recovery was found to be 99.41% for MOXI and 99.69% for BETA. The assay percentage was found to be 101.82% and 98.40% for MOXI and BETA respectively. All the validation parameters were checked according to ICH guidelines.

Keywords: Moxifloxacin, Betamethasone Sodium Phosphate, HPLC, Validation.


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