Analytical method development and validation for simultaneous estimation of Moxifloxacin Hydrochloride and Ketorolac Tromethamine by using RP-HPLC

The main objectives of the present research were to develop the new method for the simultaneous estimation and validation of Moxifloxacin HCl and Ketorolac Tromethamine in pure form and in pharmaceutical dosage form by RP-HPLC. The chromatogram of Moxifloxacin HCl and Ketorolac Tromethamine was developed through column (Inertsil ODS C18), UV detection at 304 nm at a flow rate of 1.0 ml/min with Buffer (pH 4.0):Acetonitrile:Methanol (50:30:20) V/V as mobile phase. The method was validated by various validation parameters such as accuracy, precision, linearity, specificity as per the ICH guidelines. A linearity range of Moxifloxacin HCl and Ketorolac Tromethamine was found to be 60 to 140 µg/ml and 48 to 112 µg/ml respectively. The retention time of Moxifloxacin HCl and Ketorolac Tromethamine was found to be 2.07 min and 4.06 min respectively. % RSD of retention time and peak areas obtained in system precision for Moxifloxacin HCl was 0.21 and 0.80 respectively and for Ketorolac Tromethamine were 0.90 and 1.06 respectively. The % recovery of standard Moxifloxacin HCl and Ketorolac Tromethamine was found to be 100.18 to 100.08% and 99.97 to 99.93% respectively. The % recovery of Moxifloxacin HCl and Ketorolac Tromethamine in dosage form was found to be 98.73 to 100.92% and 98.10 to 100.77% respectively. This method was simple, accurate, precise, and sensitive. Hence, the developed method was employed for the routine analysis of Tenofovir in the pharmaceutical dosage form.