STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF RABEPRAZOLE SODIUM AND LEVOSULPIRIDE IN CAPSULE DOSAGE FORM

Abstract

A Stability indicating Reverse-Phase liquid chromatographic method for the simultaneous estimation of RPS and LSP was developed. The chromatographic assay involves the use of C ₁₈ Column (150 4.6mm, with particle size 5?m) with a simple mobile phase composition (Phosphate Buffer pH-3.3 and Methanol 55:45 v/v) at a flow rate of 1mL/min with U.V detection at wavelength of 230 nm. The method showed good linearity in the concentration range of 90.0-210.0 ?g/mL for LSP and 24.056.0 ?g/mL for RPS. The proposed method was also successfully applied to 20 tablets of marketed formulation (Neopride). The developed method was successfully validated as per the ICH guidelines for following parameters. Accuracy, precision, repeatability, ruggedness, robustness, system suitability tests, etc. The RSD for Intra-day and Inter-day precision was found to be 1.02-1.83, 0.96-1.42 For LSP and 0.55-0.59, 0.75-0.63 for RPS. Average Percent recovery was found to be 980.2, 100.570.2, 99.800.2 for LSP and 101.380.2, 98.670.2, 99.530.2 for RPS which was a good agreement with labeled amount of pharmaceutical formulation. The stability indicating capacity was tested by accelerated degradation of marketed formulation in acidic (0.1 N HCl), basic (0.1 N NaOH), Neutral (water), Oxidative (3% H ₂ O ₂ ), Thermal (60 ⁰ C), Sunlight exposure.