Development and Validation of Dual Wavelength Uv Spectrophotometric Method for Simultaneous Estimation of Ambroxol Hydrochloride and Desloratadine Hydrochloride in Their Combined Tablet Dosage Form

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical dual wavelength spectrophotometric method for the simultaneous determination of Ambroxol Hydrochloride and Desloratadine Hydrochloride in combined tablet dosage form. The principle for dual wavelength method is “the absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The method was based on determination of Ambroxol Hydrochloride at the absorbance difference between 253.2 nm and 258.5 nm and Desloratadine Hydrochloride at the absorbance difference between 301.2 nm and 314 nm. The linearity was obtained in the concentration range of 5 75μg/ml for both Ambroxol Hydrochloride and Desloratadine Hydrochloride. The method was successfully applied to pharmaceutical dosage form because no interference from the tablet excipients was found. The suitability of these methods for the quantitative determination of Ambroxol Hydrochloride and Desloratadine Hydrochloride was proved by validation and recovery study. The proposed methods were found to be simple and sensitive for the routine quality control application of Ambroxol Hydrochloride and Desloratadine Hydrochloride in pharmaceutical tablet dosage form. INTRODUCTION: Ambroxol Hydrochloride (AMB) is chemically Trans – 4 – (2 – Amino 3, 5 – dibromobenzylamino) – cyclohexanol 1 is a secretolytic agent used in the treatment of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma . It is official in Indian Pharmacopoeia (IP) and British Pharmacopoeia (BP). IP 1 describes High Performance Liquid Chromatography (HPLC) method and BP 3 describes HPLC, Spectrophotometric and High Performance Thin Layer Chromatography (HPTLC) method. Literature survey also reveals Spectrophotometric , HPLC , Ultra Performance Liquid Chromatography (UPLC) 8 and HPTLC 9 methods for determination of AMB with other drugs. Desloratadine Hydrochloride (DES) is chemically 8-chloro-6, 11-dihydro-11-(4piperdinylidene) 5H benzo [5, 6] cyclohepta [1, 2-b] pyridine 10 is a second generation antihistaminic drug. It is used for the relief of symptoms of seasonal allergic rhinitis, perennial (non-seasonal) allergic rhinitis and for the symptomatic treatment of pruritus and urticaria (hives) associated with chronic idiopathic urticaria .