Sagar VLN*, Sharma GVR, Omprakash G, Bharat KB
An Ultra Performance Liquid Chromatography (UPLC) impurity profile method for the Risedronic acid monohydrate was validated in the present work. The validation method utilizes an Inertsil C-8 (100X4.6 mm), 5μ column at 50°C temperature, isocratic elution with aqueous sodium phosphate buffer at pH 7.5±0.05 and methanol as the mobile phase. The mobile-phase flow rate was 0.40 mL min–1. The linearity, method precision, method ruggedness, limit of quantitation and limit of detection of the impurity profile UPLC method are found to be satisfactory. This study showed that 3-acetylpyridine peak was well resolved from the other known impurities and Risedronic acid monohydrate, the purity angle of 3-acetylpyridine is less than the purity threshold and there is no blank interference at the retention time of 3-acetylpyridine peak. Therefore the method is determined to be specific, as judged by resolving 3-acetylpyridine content in Risedronic acid monohydrate by UPLC.
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