高效液相色谱法测定佐米曲坦制剂含量的建立与验证

Richa I. Champaneria, Bhavini K. Gharia, Ashish D. Mishra, Shailesh A. Shah
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Development and Validation of HPLC Method for Estimation of Zolmitriptan in its Pharmaceutical Dosage Form
A new simple, accurate and precise HPLC method have been developed and validated for estimation of Zolmitriptan in its pharmaceutical dosage form. In RP-HPLC method, a C18 column and methanol: water in the ratio of 75:25 (v/v %), pH adjusted to 3 using 10% orthophosphoric acid were used at a flow rate of 1.0 mL/min and detected at 222 nm. The retention time for zolmitriptan was found to be 3.6 min. The developed method was validated for linearity, precision, accuracy, specificity, LOD and LOQ as per ICH guidelines. Linearity was observed in the range of 10-50 μg/mL for zolmitriptan and correlation coefficient was found to be 0.9979. LOD and LOQ for Zolmitriptan were found to be 2.84 μg/mL and 8.62 μg/mL respectively. The % recovery was found to be 99.87%–101.57%. The method was applied for estimation of Zolmitriptan in its pharmaceutical dosage form. The assay result was found to be 95.98 ± 1.82 of percentage label claim of Zolmitriptan.
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