Development and Validation of RP-HPLC Method for Simultaneous Estimation of Levosulpiride and Pantoprazole in Combined Pharmaceutical Dosage Form
Journal Title: International Journal of Pharma Research and Health Sciences - Year 2014, Vol 2, Issue 6
Abstract
The objective of present work was to develop and validate a simple, accurate,precise HPLC method for the estimation of levosulpiride and pantoprazole. The chromatographic separation was achieved on a Hypersil BDSC18column (4.6x250 mm, 5μmparticlesize).Different mobile phase systems in different proportions were tried. For HPLC method a mobile phase consisting of K2HPo4 and acetonitrile(70:30) produced symmetric peak shape with good resolution for both the drugs. Next, the drugs were chromatographed under different flow rates from which a flow rate of 1.2 ml/min was selected. The retention timesof Levosulpiride and Pantoprazole were found to be 8.77 min and 2.77 min, respectively.The proposed method was found to have excellent linearity in the concentration range of 1-7 μg/ml with correlation coefficient r2=0.999 and 0.999 for Levosulpiride and Pantoprazole repe ctively.The method was validated for linearity, precision, LOD, LOQ and robustness.The proposed method optimized and validated as per ICH guidelines.
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