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Title : Stability indicating HPLC method for the determination of Dacarbazine in pharmaceutical dosage form
Authors : M.L. Lal Prasanth, Sridhar Siddiraju
Abstract : A simple, rapid, and precise stability indicating HPLC method is developed for the quantitative determination of dacarbazine in pharmaceutical dosage form. The chromatographic separation of dacarbazine was achieved with an agilent eclipse XDB C18, 150 x 4.6 mm, 5m particle size analytical column using buffer and acetonitrile taken in 96:4%v/v and the response was detected at 323nm by using PDA detector. The retention time was found to be 4.333. Dacarbazine drug substance was exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Peak homogeneity data of dacarbazine is obtained by photodiode array detector in the stressed sample chromatograms, demonstrating the specificity of the method for its estimation in presence of degradation product. The described method shows excellent linearity over a range of 25–150 μg/mL. The correlation coefficient for dacarbazine was found to be 0.9999. The relative standard deviation for six measurements in two sets of dacarbazine in injection is always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of dacarbazine in pharmaceutical preparations.

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