Abstract

TO DEVELOP AND VALIDATE A NEW CHROMATOGRAPHIC METHOD FOR SIMALTANEOUS ESTIMATION OF LEVAMISOLE & MEBENDAZOLE BY USING RP-HPLC

Afra Khanam*, Sujatha Palatheeya and Raju Badhavath

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Abstract

A simple, rapid and precise reverse phase liquid chromatographic (RPHPLC) method was developed and subsequently validated for the simultaneous estimation of Levamisole and Mebendazole is a bulk drug and in a synthetic mixture. The analysis was carried out using Inertsil ODS-3V, C18(150x4.6 & 5μm) column. The separation was executed by using a mobile phase containing a buffer of pH 3.2, Acetonitrile and Mixed phosphate buffer (60:40 v/v), pumped at a flow rate of 1.0 mL/min with UV-detection at 245 nm and runtime 20min. Both the drugs were well separated with good resolution on the stationary phase and the retention times were around 4.34 minutes for Levamisole and 9.08minutes for Mebendazole. Determined the quantitative assay of levamisole and mebendazole was 98 to 102%. The method was validated and shown to be linear for Levamisole and Mebendazole. The correlation coefficients for Levamisole and Mebendazole are 0.999 and 1.000 respectively. Obtained the accuracy of drug product by this method was within the acceptance limits 98 to 102% and the % RSD of assay was below 2.0%.

Keywords: Levamisole, Mebendazole, Chromatography, Reverse phase, Validation, RPHPLC.