Abstract
A simple, precise, specific, and accurate reverse phase HPLC method has been developed for the determination of pregabalin in capsule dosage form. The chromatography was set on Hypersil BDS, C8, 150×4.6 mm, 5 μm column using photodiode array detector. The mobile phase consisting of phosphate buffer pH 6.9 and acetonitrile in the ratio of 95:05 with flow rate of 1 ml/min. The method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. Lower limit of quantification is 0.6 mg/l. The pregabalin sample solution was found to be stable at room temperature for about 26 h.
Highlights
A simple, precise, specific, and accurate reverse phase HPLC method has been developed for the determination of pregabalin in capsule dosage form
Weighed sample of pregabalin (50 mg) working standard was transferred to a 50 ml volumetric flask and 30 ml of mobile phase was added and sonicated to dissolve the sample completely
The peak purity was checked by confirming homogeneous spectral data for pregabalin in each stressed conditions and it indicates that there is no interference from related impurities and excepients
Summary
Stress degradation studies on ornidazole and development of a validated stability indicating RP-HPLC assay. Validated HPLC method for the determination of ornidazole in human serum and urine. Development and Validation of HPLC Method for the Determination of Pregabalin in Capsules
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