ABSTRACT:
Two simple, sensitive, rapid, precise UV spectrophotometric methods have been developed and validated for simultaneous estimation of Gemifloxacin mesylate and Ambroxol hydrochloride. Recently this combination of two drugs is approved for the treatment of lower respiratory tract infection mainly pneumonia and bronchitis in adult which is available in tablet dosage form. First method is simultaneous equations method, wavelength selected for estimation of Gemifloxacin mesylate and Ambroxol hydrochloride are 271 nm and 209 nm. The second method is first order derivative method based on measurement at zero crossover point of another drug, measurement of Gemifloxacin mesylate and Ambroxol hydrochloride were carried out at 262 and 218 nm respectively. The linearity was obtained in the concentration range of 2-14 µg/ml for Gemifloxacin mesylate and 1.5-10.5µg/ml for Ambroxol hydrochloride. The proposed methods are successfully applied for the simultaneous determination of both drugs in marketed tablet preparation. The method was validated with respect to linearity, accuracy, precision as per the International Conference on Harmonization (ICH) guidelines.