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Simultaneous RP-HPLC determination of gatifloxacin and ambroxol hydrochloride in pharmaceutical preparations

Manisha M.Baing, V.V.Vaidya, N.J.Rane, P.A.Champanerkar

A rapid and accurate reversed phase high performance liquid chromatographic method has been developed for the simultaneous determination of Gatifloxacin andAmbroxol hydrochloride. Ciprofloxacinwas used as internal standard. Chromatographic separation of the two drugs was performed on aBDSHypersilC18 column (150mm 4.6mm, 5m)with a 65:15:20 (v/v) mixture of 0.05Mpotassiumdihydrogen phosphate, acetonitrile, andmethanol (0.1%triethyl amine pH adjusted to 3.0 with orthophosphoric acid) at a flowrate of 1.0ml/min and detection at 220nm. The separationwas complete in less than 10 mins. The method was validated for linearity, accuracy, precision, limit of quantitation and robustness[2,3]. Linearity, accuracy and precision were found to be acceptable over the ranges of 120 - 280g mL-1 for Gatifloxacin and 18- 42gmL-1 forAmbroxol hydrochloride.