Development and Validation of RP-HPLC Method of Lafutidine (API)
Keywords:RP-HPLC, Method development, Validation, Lafutidine.
The goal of this study is to develop and validate an RP HPLC technique for estimating Lafutidine in bulk form. A thorough review of the literature found that there are ways available, but none of them are as straightforward, specific, exact, or accurate as the established approach for estimating Lafutidine. The chromatographic method was found to be suitable for effective separation of Lafutidine with good resolution, peak shape. The mobile phase composed of 0.1M ammonium acetate buffer (pH 7.5): Methanol (80:20 v/v), at a flow rate of 1.4 ml/min was selected as it gave well resolved peaks of standard Lafutidine. The optimum wavelength 290nm selected for detection and quantitation. According to ICH criteria, the devised approach was validated.
Keywords: , , ,