Abstract

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.

Highlights

  • Zolmitriptan is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist

  • The developed method was validated for linearity, precision, accuracy, specificity, LOD and LOQ as per ICH guidelines

  • In RP-High-Performance Liquid Chromatography (HPLC) method, a C18 column and methanol: water in the ratio of 75:25 (% v/v) pH adjusted to 3.0 using 10% orthophosphoric acid were used at a flow rate of 1.0 mL/min and detected at 222 nm

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Summary

INTRODUCTION

Zolmitriptan is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Several methods for the estimation of Zolmitriptan have been described in the literature which include spectrophotometric method [1,2,3], High-Performance Liquid Chromatography (HPLC) method [4,5,6], colorimetry [7], capillary chromatography [8,9], differential pulse and square wave voltammetry [10,11]. While HPLC methods were reported for the determination of zolmitriptan in human plasma using fluorescence detection, liquid chromatography-electrospray mass spectrometry [12,13], coulometric detection [14]. These techniques are very time consuming and required sophisticated instrumentation and not suitable for real-time analysis. Literature survey reveals that there was no method reported using isocratic RP-HPLC (without using buffers) for estimation of Zolmitriptan in its Nasal spray formulation [16]. The developed method was validated for linearity, precision, accuracy, specificity, LOD and LOQ as per ICH guidelines

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