DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF LEVAMISOLE IN BULK AND DOSAGE FORM
Objective: To develop a reverse phase isocratic HPLC was developed and validated for the determination of levamisole in bulk and tablet dosage forms.
Method: Method development was carried out on Welchrom C18 isocratic column, (250 mm Ã— 4.6 mm i.d., particle size 5 Î¼m, maintained at ambient temperature), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase was a mixture of Methanol: Acetonitrile: Water 50:30:20 v/v, with apparent pH of 4.6 and the flow rate was set at 1.0 ml/min and UV detection at 225 nm. Results: Validation parameters were evaluated for the method according to the ICH (Q2R1) guidelines. In the linearity study, linearity was observed from 2-10 Î¼g/ml with correlation coefficient of 0.9999 and regression coefficient of 0.9998. The limit of detection and limit of quantitation for the method were 0.1219 Î¼g/ml and 0.3695 Î¼g/ml, respectively. The statistical analysis shows that the method was found to be accurate, reliable, simple and reproducible. The intra- and inter-assay precisions were satisfactory; the values of relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of levamisole was 99.36% to 100.56%. The chromatographic retention time of proposed method was 2.790 min and the mean assay of content was found to be 102.135 Â± 0.933%.
Conclusion: The proposed method was successfully applied for the quantitative determination of levamisole in bulk form and could be used for routine analysis with phenomenal accuracy and precisions.
Keywords: RP-HPLC, Levamisole, Validation, ICH guidelines.
Drug today medical journal, Lorina publication (India) Inc., Delhi-91, 2012, DT 78, Vol-1:588.
Switi B, Gaikwad, Krishnamohan. GImmnomodulatory activity of methanolic extract of Thespesia populnea leaves in wister albuno rats. Asian J of Pharm Clin Res 2011; 4(4):99-101.
El-Didamony AM. Spectrophotometric determination of benzydamine HCl, levamisole HCl and mebeverine HCl through ion-pair complex formation with methyl range. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 2008; 69(3):770-775.
Garcia JJ, Diez MJ, Sierra M, TerÃ¡n MT. Determination of levamisole by HPLC in plasma samples in the presence of heparin and pentobarbital. Journal of Liquid Chromatography 1990; 13(4):743-749.
De Bukanski BW, Degroodt JM, Beernaert H. Determination of levamisole and thiabendazole in meat by HPLC and photodiode array detection. Zeitschrift fÃ¼r Lebensmittel-Untersuchung und Forschung 1991; 193(6):545-547.
Marriner S, Galbraith EA, Bogan JA. Determination of the anthelmintic levamisole in plasma and gastro-intestinal fluids by high-performance liquid chromatography. Analyst 1980; 105(1255):993-996.
Vandamme TF, Demoustier M, Rollmann B. Quantitation of levamisole in plasma using high performance liquid chromatography. European journal of drug metabolism and pharmacokinetics 1995; 20(2):145-149.
Sari P, Sun J, Razzak M, Tucker IG. HPLC assay of levamisole and abamectin in sheep plasma for application to pharmacokinetic studies. Journal of liquid chromatography & related technologies 2006; 29(15):2277-2290.
Du Preez JL, LÃ¶tter AP. Solid-phase extraction and HPLC determination of levamisole hydrochloride in sheep plasma. The Onderstepoort journal of veterinary research 1996; 63(3):209.
Sari P, Razzak M, Tucker IG. Rapid, simultaneous determination of levamisole and abamectin in liquid formulations using HPLC. Journal of liquid chromatography & related technologies 2005; 27(2):351-364.
Cannavan A, Blanchflower WJ, Kennedy DG. Determination of levamisole in animal tissues using liquid chromatography-thermospray mass spectrometry. Analyst 1995; 120(2):331-333.
Chappell CG, Creaser CS, Stygall JW, Shepherd MJ. Onâ€line highâ€performance liquid chromatographic/gas chromatographic/tandem ion trap mass spectrometric determination of levamisole in milk. Biological mass spectrometry 1992; 21(12):688-692.
ICH, Harmonized Tripartite Guideline. Validation of Analytical Procedure: Methodology (Q2B). International Conference on Harmonization, 1997.
How to Cite
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.