Bilastine: stability-indicating a method using environmentally friendly by reversed-phase high-performance liquid chromatography (RP-HPLC)

Drug Analytical Research Pub Date : 2022-07-28 DOI:10.22456/2527-2616.120940

Paulo Roberto Rodrigues Martini, Douglas Dos Santos Porto, Paola Ribeiro Motta, Lisiane Bajerski, Marcelo Donadel Malesuik, Clésio Soldateli Paim

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Abstract

This study describes the development and validation of a new environmentally friendly analytical method for the determination of bilastine in coated tablets and the evaluation of its capacity to be stability-indicating as well. The ecofriendly analytical method was validated by specificity, linearity, accuracy, precision and robustness by reversed-phase high-performance liquid chromatography (RP-HPLC) according to International Conference on Harmonization guidelines (ICH) and Association of Official Analytical Chemists (AOAC). Isocratic LC separation was achieved on a RP18 column using a mobile phase of sodium dihydrogen phosphate aqueous buffer solution adjusted to pH (6.0 ± 0.1) with o-phosphoric acid (85% v/v) and triethylamine (0,3% v/v) and ethanol (EtOH) in the following proportions (60:40 v/v), at a flow rate of 1.0 mL·min-1 at temperature-controlled at 30 °C. The analytical method showed selectivity, good recovery and precision (intra- and inter-day), robustness, and linear over a range from 5.0 to 50 μg·mL-1.

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本研究建立了一种新的环境友好的测定包衣片中胆碱的分析方法，并对其稳定性进行了评价。采用反相高效液相色谱法(RP-HPLC)，按照国际统一指南会议(ICH)和官方分析化学家协会(AOAC)的要求，对该环保分析方法进行了特异性、线性、准确度、精密度和鲁棒性验证。色谱柱为RP18，流动相为磷酸二氢钠缓冲水溶液，pH值为(6.0±0.1)，o-磷酸(85% v/v)，三乙胺(0.3% v/v)，乙醇(EtOH)，比例为60:40 v/v，流速为1.0 mL·min-1，温度控制在30℃。该方法在5.0 ~ 50 μg·mL-1范围内具有良好的选择性、回收率和精密度(日内和日间)、稳健性和线性性。

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Drug Analytical Research

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