METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LORATADINE IN TABLET DOSAGE FORM BY RP-UHPLC

Analytical method for the combination of Ambroxol and Loratadine by UHPLC is not reported till date. Hence UHPLC method has been developed and validated for the estimation of Ambroxol hydrochloride and Loratadine in tablet dosage form. The separation was carried out using a UHPLC column Waters C18 column (50 mm x 4.6 mm, 3.5µ) and further elution was optimized using degassed mobile phase containing a mixture of 300 volumes of Methanol, 300 volumes of phosphate buffer pH 6.0 and 400 volumes Acetonitrile. The retention time for Ambroxol Hydrochloride and Loratadine was found to be 1.96 min and 3.41 min respectively. The validation results were found to be linear in the concentration range of 300-900µg/ml for Ambroxol Hydrochloride and 25-75µg/ml for Loratadine with corresponding correlation co-efficient of 0.9996 and 0.9994 respectively. The percentage recovery was found to be 99.55% for Loratadine and 99.12% for Ambroxol Hydrochloride. The amount of drug in the formulation was found to meet with the label claim and the percentage assay was 59.737 mg (99.56%) for Ambroxol Hydrochloride and 4.9574 mg (99.15 %) for Loratadine. The results showed that this proposed UHPLC method to be specific, accurate, precise, linear, and rugged for determination of Ambroxol hydrochloride and Loratadine in pharmaceutical dosage form, the validation of method was carried out according to ICH guidelines.