STABILITY INDICATING BIOANALYTICAL METHOD AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LEVOSULPIRIDE AND RABEPRAZOLE SODIUM IN HUMAN PLASMA BY RP-HPLC

Aim: To developing, stability indicating validating bioanalytical method for the estimation of Levosulpiride and Rabeprazole Sodium by RP-HPLC method which is expected to be accurate, precise, linear, stable and selective Methods of measuring drugs in biologic media are increasingly important problems related to bioavailability and bioequivalence, new drug development, drug abuse, clinical pharmacokinetics, and drug research are highly dependent on accurately measured drugs in biological fluids. Method: to development of New Bioanalytical method for estimation in combined oral solid formulation of Levosulpiride and Rabeprazole Sodium. Stationary phase Hibra C18(250×4.6 mm i.d.,5µ) column at wavelength of 240nm. Using 10mM ammonium acetate is mobile phase in an isocratic elution mode at a flow ratio 0.8ml/min. Result: the retention time of Levosulpiride and Rabeprazole Sodium were 9.92 and 4.27min respectively and internal standard RT was 12.04min, therefore no interference between internal standard and drug peaks. Quantitation was achieved with UV detect in at 240nm based on peak areas with linearity concentration ranges 0.024-2.4 µg/ml for levosulpiride, 0.024-1.24 µg/ml for rabeprazole sodium (R2 value 0.9985 and 0.9993). The LOD’s were 0.003µg/ml, LOQ’s found to be 0.009µg/ml and 0.01µg/ml respectively. Conclusion: the developed method for the estimation of Levosulpiride and Rabeprazole in plasma is rugged, rapid, sensitive, precise, selective and linear and is therefore, can be employed for a bioequivalence study to evaluate its applicability further