Abstract
A METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF ZOLMITRIPTAN CONTENT IN ZOLMITRIPTAN PHARMACEUTICAL DRUGS PRODUCT
Sushil H. Jaiswal*, Dr. M. V. Katariya, Dr. V. R. Katariya Dr. G. S. Karva and Dr. U. R. Maniyar
ABSTRACT
A reversed-phase high performance liquid chromatography (RP-HPLC).[1] method was developed and validated for the estimation of Zolmitriptan in pharmaceutical drugs dosage forms. The separation was achieved on Inertsil C8 –3, (150 mm X 4.6 mm), 5?m using the gradient composition of phosphate buffer pH 7.5 as mobile phase A and mixture of methanol and buffer pH 7.5 in the ratio of 750:250 v/v as mobile phase B at flow rate 1.5mL per minute and detection wavelength 285 nm. The retention time of Zolmitriptan was about 7.2 min. The method for the quantitative determination of Zolmitriptan in Zolmitriptan tablets was validated. The method was evaluated for its specificity, precision, solution stability, accuracy, linearity and range, and robustness. The method was developed and validated under the light of International Conference on Harmonization (ICH) guidelines.[2,3,4] And for the statistical evaluation of results, standards guidelines were followed.[5]
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