ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LEVOSULPIRIDE AND PANTOPRAZOLE IN TABLETS BY RP-HPLC METHOD
Abstract
A simple, precise, accurate, rapid and economical reverse phase high-pressure liquid chromatographic method has been developed as per ICH norms for the simultaneous estimation of Levosulpride and pantoprazole sodium from pharmaceutical formulation. The method was carried out on a Column – C18 (250mm x 4.6mm x5 µ) with a mobile phase consisting of buffer (adjusted to pH6.8 with 1% triethylamine): Acetonitrile (65:35v/v) and filtered through 0.45µ cellulose nitrate filters. The flow rate 1.0mL/min. Detection was carried out at 280 nm. The retention time of LVS and PNT was 2.41 and 6.86 min respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms.
Key words: RP-HPLC, Levosulpride, Pantoprazole, Validation
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