Forced Degradation Studies of Ambroxol Hydrochiloride and Desloratadine

Abstract

A fixed dose combination containing Ambroxol (75mg) & Desloratadine (5mg) is available in tablet form in the market. A few methods have been reported individually or in combination with other drugs for simultaneous estimation by UV detection, Spectrophotometric method, High performance liquid chromatographic (RP-HPLC), HPTLC, Mass spectroscopy or Ultra high performance chromatography (UPLC). The present research attempts to provide comprehensive information & compare the reported method by developing simultaneous determination of Ambroxol HCl & Desloratadine by RP-HPLC. The chromatographic separation was carried on Intersil 3V ODS (250mm x 4.6mm, 5 µm) Column using Phosphate Buffer (pH 3.3 with OPA): ACN ratio of 70: 30 at flow rate of 1 mL/min. The eluent was detected at 248nm. The sharp peak was retented at 4.13 min & 5.76 min. The linearity having correlation coefficient (R2) above 0.99. The mean % recovery was found to be within in the range 98-102%. The LOD for AMB & DES was 1.69 & 0.35 µg/mL. The LOQ for AMB & DES was 5.11 & 1.06 µg/mL. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The method was successfully applied for Prepared Capsule Formulation containing 75 mg Ambroxol HCl & 5 mg Desloratadine for Dissolution Studies, Content Uniformity of Desloratadine & Assay of Prepared Capsule Formulation. Forced Degradation Studies was also carried under Acid, Alkaline, Hydrogen Peroxide and Thermal. Stressed samples were assayed using developed HPLC method.