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RP-HPLC method for the simultaneous estimation of ambroxol hydrochloride and desloratadine in pure and dosage form | Abstract
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Abstract

RP-HPLC method for the simultaneous estimation of ambroxol hydrochloride and desloratadine in pure and dosage form

Author(s): G. Babu, Shirin K and R. Rajapandi

A simple, fast, accurate, precise, method has been developed for the simultaneous estimation of Ambroxol hydrochloride and Desloratadine in pure and tablet dosage form by reversed-phase high performance liquid chromatography. The separation was carried out on C18 Phenomenex column, using mobile phase consisting of a mixture of acetonitrile: potassium dihydrogen orthophosphate buffer in the ratio 25: 75 and pH adjusted to 3.9 using orthophosphoric acid. The flow rate was adjusted to 1 ml/min. the UV detection was carried out at a wavelength of 270 nm. The retention time of Ambroxol hydrochloride and Desloratadine was found to be 4.4 min and 6.6 min respectively. Linear response obtained for Ambroxol hydrochloride was in the concentration range 3-15 μg/ml (r2 = 0.999) and Desloratadine in the range 0.2-1 μg/ml (r2 = 0.999). The relative standard deviation in the tablets was found less than 2% for six replicates. The method was validated according to ICH guidelines with respect to linearity, precision, limit of detection, limit of quantitation, accuracy, ruggedness, and robustness. Thus, proposed method can be successfully applicable to the pharmaceutical preparation containing the above mentioned drugs without any interference of excipients