Reverse - Phase High - Performance Liquid Chromatographic Method Development and Validation for the Estimation of Eletriptan Hydrobromide in Tablet Formulations

Abstract

A fast, sensitive, specific, and reliable RP - HPLC technique was developed and validated for the determination of Eletriptan Hydrobromide in tablet dosage forms. Chromatographic separation was accomplished by employing a Waters X - Terra RP18 column (250 × 4.6 mm, 5 μm) stationary phase. Mobile Phase A comprising of water, phosphate buffer (pH 7.2), and acetonitrile in the ratio of 20:10:70 (v/v/v), whereas Mobile Phase B comprised of acetonitrile and methanol in the ratio of 80:20 (v/v). The analysis was carried out using a flow rate of 1.0 mL/min with detection by a UV detector at wavelength of 225nm. Under the optimum condition s of chromatography, Eletriptan Hydrobromide yielded a well - defined and symmetrical peak with a retention time of about 5.06 min, and total run time of 10 min for each analysis. The proposed method was validated according to the ICH guidelines for the assessment of system suit ability, specificity, linearity, accuracy, precision, range, and robustness. The linearity of calibration curve was good over the concentration range from 25% to 150% of the target assay concentration.The accuracy studies revealed good recovery, whereas the precision studies proved the reproducibility of the method with acceptable % RSD values. Intentional changes in the analytical parameters revealed that the method was very robust without any loss in per formance. The developed RP - HPLC method was effectively utilized for the quantification of Eletriptan Hydrobromide in the marketed formulations of tablets. Due to the simplicity, sensitivity, precision, and reproducibility of the method, it can be used for quality control analysis.