Abstract
The objectives of this investigation were to establish a validated stability-indicating LC method for assay of carvedilol and to study the degradation behaviour of the drug under different ICH-recommended stress conditions. Chromatographic separation was achieved on a C18 column with 55:45 (%, v/v) acetonitrile–0.02 m phosphate buffer, pH 3.5, as mobile phase at a flow rate of 1.0 mL min−1; detection was by UV absorbance at 242 nm. The method was validated for linearity, precision, accuracy, robustness, specificity, and sensitivity, with the bulk drug. The drug was subjected to forced degradation and peaks of all the degradation products were well resolved from that of the pure drug, with significantly different retention times, which indicates the specificity and stability-indicating properties of the method. First-order degradation kinetics of carvedilol were observed under acidic and alkaline conditions. When the utility of the method was verified by analysis of the drug in marketed tablets and a nano-emulsion formulation, the assay was found to be 98.60–99.61 and 99.52–99.87, respectively. These results indicate the method can be successfully used for routine analysis of carvedilol in the bulk drug and in pharmaceutical dosage forms.
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Acknowledgment
The authors would like to thank Wockhardt Research Center, Aurangabad, Maharashtra, India for the gift sample of carvedilol. Mohammad Rizwan is the recipient of a Research Fellowship in Science under the RFSMS scheme (#F.4-3/2006 (BSR)/11-26/2008 (BSR) of the University Grants Commission (UGC), New Delhi.
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Rizwan, M., Aqil, M., Azeem, A. et al. Study of the Degradation Kinetics of Carvedilol by Use of a Validated Stability-Indicating LC Method. Chroma 70, 1283–1286 (2009). https://doi.org/10.1365/s10337-009-1294-6
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DOI: https://doi.org/10.1365/s10337-009-1294-6