HPTLC AND HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF RABEPRAZOLE SODIUM AND LEVOSULPIRIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

摘要

Objective: Two methods are described for the simultaneous estimation of Rabeprazole sodium and Levosulpiride in the binary mixture. Methods: The two methods are HPTLC and HPLC methods. Results: The first method was based on the HPTLC of the two drugs. The separation was carried out on Merck HPTLC precoated silica gel 60 F254aluminium sheets, using Toluene: Methanol: Triethylamine (7:3:0.2, v/v/v) as mobile phase. Quantitation was achieved with UV detection at 280 nm based on peak area with calibration curves at concentration ranges 100-500 ng/spot and 375-1875 ng/spot for Rabeprazole sodium and Levosulpiride, respectively. The Rf for Levosulpiride and Rabeprazole Sodium was found to be 0.52 ± 0.02 and 0.71 ± 0.02 respectively. The second method was based on the HPLC separation of the two drugs on the reverse phase, Grace smart [C18(5μm, 25 cm × 4.6 mm)] using a mobile phase consisting of Acetonitrile: Water: Triethylamine (35:65:1.0 v/v/v) and adjusting the pH to 7.0 with 10 % orthophosphoric acid. Quantitation was achieved with UV detection at 290 nm with linear calibration curves at 4-14 μg/mL and 15-52.5 μg/mL for Rabeprazole sodium and Levosulpiride, respectively. The retention times for Levosulpiride and Rabeprazole Sodium were found to be 3.98 ± 0.02 min and 5.84 ± 0.02 min respectively. Conclusions: The developed HPTLC and HPLC methods are precise, specific and accurate. These methods can be used for routine quality contro l process in the laboratory