Article Details

Development and Validation of Rp-Hplc Method for the Determination of Zolmitriptan in 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.

Analytical Research & Development Division, Indian Pharmacopoeia Laboratory, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sec–23, Raj Nagar, Ghaziabad 201002, Uttar Pradesh, India.

*E-mail:raman19662002@gmail.com


ABSTRACT

A convenient, simple, accurate, precise and reproducible Reverse Phase High Performance Liquid Chromatography method was developed and validated for the estimation of zolmitriptan in the bulk drug and tablet dosage form. Objective was achieved under optimized chromatographic conditions on Dionex UHPLC system with Dionex C18 column (250 × 4.6 mm, 5 mcm particle size) using mobile phase composed of methanol and 0.005 M ammonium acetate in the ratio of 50:50 V/V. The separation was achieved using an isocratic elution method with a flow rate of 1 mL/ min at room temperature. The effluent was monitored at 230 nm using diode array detector. The retention time of zolmitriptan was found to be 3.4 minutes and the standard calibration plot was linear over a concentration range of 10–120 mcg/ mL with 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 the stated amount respectively. The method was validated statistically using the %RSD and the values are found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 99.2± 0.5706 %. So, the proposed method was found to be simple, specific, linear, and robust. Hence this method was conveniently and easily applied for routine analysis of zolmitriptan in bulk drug and tablet dosage form.

Year 2013 | Volume No. 50 | Issue No.8 | Page No. 20-26
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