Analytical Method Developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP-HPLC in Combination Dosage Form

Abstract

A rapid and precise method (in accordance with ICH guidelines) is required for the quantitative simultaneous determination of drugs in a combined pharmaceutical dosage form. The pursuit of desired quality is a continual challenge for pharmaceutical industries, necessitating a meticulous approach known as validation. Sensitive and specific RP-HPLC method involving UV detection was carried for determination and quantification of various drug in combination dosage form. The aim is "Analytical Method developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP- HPLC In Combination Dosage Form " as per ICH guidelines. The developed method was validated for various parameters as per ICH guidelines like system suitability, specificity, linearity, system precision, method precision, accuracy, ruggedness and robustness. The separation method was carried out by using a mobile phase A consisting of Potassium dihydrogen phosphate buffer (0.05M): Methanol 45:55 v/v) pH 3.5 ± 0.1 and Mobile phase B comprises Acetonitrile in the ratio of 50:50 v/v. The detection was carried out by using UV detector at 300nm. The column was Agilent C 18 (250X4.6mm) 5µ. The flow rate was selected as 1.5 ml/min. The retention time of Ofloxacin, Lidocaine, Beclomethasone, and Clotrimazole, was found to be 5.67, 9.44, 18.29, and 21.85 respectively.