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Development and Validation of an RP-HPLC Method for the Simultaneous Determination of LevamisoleHCl and Oxyclozanideand its Application in the Assay of Veterinary Bolus Formulations

Author(s):

Kemal Hussien Seid, Tarekegn Berhanu, Kaleab Asres and Ayenew Ashenef*   Pages 1 - 11 ( 11 )

Abstract:


Introduction:A reverse-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous analysis of two drugs, levamisole hydrochloride(LH) and oxyclozanide(OX), in co-formulations for veterinary use.

Materials and Methods: The new HPLC method was validated per ICH and other guidelines. A C18 column was used with agradient program; eluent A was an equal mixture of methanol and acetonitrile, and eluent B a 25 mM phosphate buffer at pH 7.0 containing 30 mM sodium decanesulfonate andtriethylamine(50:50:1 v/v)then pH adjusted to 7.0 with H3PO4 [51:49 v/v] .The detection wavelength was set at 220 nm.For the final gradient program, the retention times were 8.2(for LH)and 13.6(for OX) minutes respectively at flow rate of 1 ml/min over 20 minute run time.

Results:The method wasprecise, specific and robust.The correlation coefficients, R2 were 0.9998 and 0.9999 for LH and OX respectively in the ranges of 5 – 280 µg / mL.The percent y-intercepts and percent residual standard deviations were 1.6%/0.4% and 1.4%/1.0% for LH and OX, respectively. The LOD and LOQ of the method were 0.21 µg / mL and 0.62 µg / mL for LHand 0.06 µg / mL and 0.18 µg / mL for OX. The method has average accuracy of 100.5% for LH and 101.1% for OX when tested on veterinary bolus formulations, and the samples couldbe stored under typical lab conditions for about 7 days without significant degradation.

Conclusion: This HPLC method is suitable forassayinglevamisole hydrochloride and oxyclozanide simultaneously from veterinary formulations.

Keywords:

Analytical method Development, Bolus formulations, RP-HPLC, Levamisole, Oxyclozanide

Affiliation:

Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O.Box. 1176, Addis Ababa, Previously Pesticides Residue analysis Laboratory, Federal Ministry of Agriculture, Addis Ababa, Ethiopia.CurrentlyAcademic Vice President, Department of Industrial Chemistry, Addis Ababa Science and Technology University, P. O. Box.16417, Addis Ababa, Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O.Box. 1176, Addis Ababa, Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O.Box. 1176, Addis Ababa



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