Validation of a Stability-Indicating LC Method for Assay of Ezetimibe in Tablets and for Determination of Content Uniformity
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- Doshi, A.S., Kachhadia, P.K. & Joshi, H.S. Chroma (2008) 67: 137. doi:10.1365/s10337-007-0470-9
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A simple, precise, and accurate HPLC method has been developed and validated for assay of ezetimibe in tablets and for determination of content uniformity. Reversed-phase liquid chromatographic separation was achieved by use of phosphoric acid (0.1%, v/v)–acetonitrile 50:50 (v/v) as mobile phase. The method was validated for specificity, linearity, precision, accuracy, robustness, and solution stability. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug (forced degradation). Response was a linear function of drug concentration in the range 20–80 μg mL−1 (r = 0.9999). Intraday and interday system and method precision were determined. Accuracy was between 100.8 and 102.7%. The method was found to be robust, and was suitable for assay of ezetimibe in a tablet formulation and for determination of content uniformity.