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Development and Validation of Rp-Hplc Method for the Determination of Zolmitriptanin Bulk Drug and Tablet Dosage Form

Arora P. K., Chauhan A., Duggal D., Saini P. K., Mathur S. C., Singh R M.* and Singh G. N.


ABSTRACT

A convenient, simple, accurate, precise and reproducible Reverse Phase High Performance LiquidChromatography method was developed and validated for the estimation of zolmitriptan in the bulkdrug and tablet dosage form. Objective was achieved under optimized chromatographic conditions onDionex UHPLC system with Dionex C18 column (250 4.6 mm, 5 mcm particle size) using mobile phasecomposed of methanol and 0.005 M ammonium acetate in the ratio of 50:50 V/V. The separation wasachieved using an isocratic elution method with a flow rate of 1 mL/ min at room temperature. The effluentwas monitored at 230 nm using diode array detector. The retention time of zolmitriptan was found to be3.4 minutes and the standard calibration plot was linear over a concentration range of 10120 mcg/ mLwith r2 = 0.9999. The LOD and the LOQ were found to be 3.7 mcg/ mL and 11.1 mcg/ mL respectively.The amount of zolmitriptan present in the bulk drug was 99.81 % and in the formulation 98.05 % of thestated amount respectively. The method was validated statistically using the %RSD and the values arefound to be within the limits. The recovery studies were performed and the percentage recoveries werefound to be 99.2 0.5706 %. So, the proposed method was found to be simple, specific, linear, androbust. Hence this method was conveniently and easily applied for routine analysis of zolmitriptan inbulk drug and tablet dosage form.
Year 2013 | Volume No. 50 | Issue No.8 | Page No. 20
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