Abstract
A simple, specific, precise, and accurate stability indicating RP-HPLC method has been developed and validated for the estimation Dexlansoprazole in Bulk and Capsule dosage formulation. The separation was achieved by Hypersil BDS C18 100 x 4.6 mm, 5m column using mobile phase consisting of 0.01M KH2PO4 buffer (pH adjusted to 7.0 with triethyl amine) and acetonitrile (60: 40, v/v) at a flow rate of 1.2 mL/min and detection at 283 nm. The Method was developed in isocratic mode. The retention time was around 2.45. The method showed linearity with correlation coefficient < 0.999 over the range of 25–150 𝜇g/mL .The mean recoveries were found to be in the range of 99.8–100.16% for Dexlansoprazole.LOD and LOQ values were found to be 0.0929 and 0.282 𝜇g/mL respectively. The method was validated as per the ICH guidelines for linearity, limit of detection, limit of quantification, accuracy, precision, robustness and solution stability. Stability indicating capability of the developed method was established by analyzing forced degradation of samples with separation of degradation products from analytes peak was achieved. The method can be successfully applied for routine analysis of quantitative determination of Dexlansoprazole in pharmaceutical dosage form.
