DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF LEVAMISOLE IN PURE AND DOSAGE FORMAbstract
A reverse phase isocratic HPLC was developed and validated for the determination of levamisole in pure and tablet dosage forms. Method development was carried out on YMC C18 isocratic column, (250 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature), Shimadzu LC–sol 2010 Prominence Liquid Chromatography. The mobile phase was a mixture of Acetonitrile: methanol 50:50 v/v and the flow rate was set at 1.3 ml/min and UV detection at 236 nm. Validation parameters were evaluated for the method according to the ICH guidelines. In the linearity study, linearity was observed from 2-10 μg/ml with a correlation coefficient of 0.9999 and regression coefficient of 0.999. The limit of detection and limit of quantitation for the method were 0.0209μg/ml and 0.069μg/ml, respectively. The statistical analysis shows that the method was found to be accurate, reliable, simple, and reproducible. The intra and interassay precisions were satisfactory; the values of relative standard deviations did not exceed 2%. The accuracy of the method was proved; the recovery of levamisole was within limits. The chromatographic retention time of the proposed method was 3.3 min, and the assay of content was found to be 98.9%-100.8%. The proposed method was successfully applied for the quantitative determination of levamisole in pure form and could be used for routine analysis with phenomenal accuracy and precisions.
T. R. Gupta *, B. Bonthagarala, A. L. Harini, S. Arifun, V. Prathusha and G. D. Rao
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, SIMS Group of Institutions, Mangaldas Nagar, Guntur, Andhra Pradesh, India.
20 February 2015
27 March 2015
28 April 2015
01 May 2015