Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2012 Vol: 4 Issue: 11

Development and validation of stability indicating UPLC assay method for bupivacaine in pharmaceutical formulation

Abstract

The present method provides the detailed description of development and validation of a simple stability indicating liquid chromatographic method for Bupivacaine Assay in the presence of Methyl paraben. Successful separation of the drug from methyl paraben was achieved with in 6min on C18, 50 x 4.6mm, 1.8μm column, using a 0.2M pH 6.8 Phosphate buffer, Acetonitrile and Milli Q water in the ratio of 5:40:650v/v/v at a flow rate of 1.0 mL per minute. Column oven temperature was selected as 45ºC where the detection was carried out at 234 nm. The developed LC method was validated with respect to specificity, linearity, accuracy, precision, ruggedness and robustness. The assay method was found to be linear in the range of 25 μg·mL–1 to with 300 μg·mL–1 correlation coefficient of 0.9999 for methyl paraben and 125 μg·mL–1 to with 900 μg·mL–1 correlation coefficient of 0.9999 for Bupivacaine. A recovery of assay of methyl paraben was found between 98.5% and 101.5% and Bupivacaine was found between 98.5% and 101.5%. The developed LC method to determine the assay of Bupivacaine can be used to evaluate the quality of regular production samples and stability samples.