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首页> 外文期刊>Pharmaceutical Methods >Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in pharmaceutical dosage form
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Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in pharmaceutical dosage form

机译：建立并验证用于同时评估药物剂型中奥美沙坦美多佐米和琥珀酸美托洛尔的稳定性指示RP-HPLC方法

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摘要

Aim and Backrgound:A simple, rapid, precise and isocratic RP-HPLC (Reverse Phase High Performance Liquid Chromatography) method is aimed to develop for the simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in bulk drug and pharmaceutical dosage form.Materials and Methods:The quantification is carried out using YMC-Pack CN (250 × 4.6 mm, 5.0 μm) column and the mobile phase comprises of 0.05% Trifluoro acetic acid (TFA) and Acetonitrile (ACN) (70:30 v/v). The flow rate is 1.0 ml/min. The eluent is monitored at 220 nm. The retention times of Olmesartan Medoxomil and Metoprolol Succinate are 7.9 min and 4.1 min respectively. The method is validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation.Results:Linearity and percentage recoveries of both Olmesartan Medoxomil and Metoprolol Succinate are in the range of 5-35 μg/ml and 100 ± 2%, respectively. The stress testing of both the drugs individually and their mixture is carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation (dry heat and wet heat) conditions and its degradation products are well resolved from the analyte peaks.Conclusion:This method was successfully validated for accuracy, precision, and linearity.
机译：目的和背景：旨在开发一种简单，快速，精确和等度的RP-HPLC（反相高效液相色谱）方法，用于同时估计散装药物和药物剂型中的奥美沙坦Medoxomil和琥珀酸美托洛尔。材料和方法：使用YMC-Pack CN（250×4.6 mm，5.0μm）色谱柱进行定量，流动相包含0.05％三氟乙酸（TFA）和乙腈（ACN）（70:30 v / v）。流速为1.0毫升/分钟。在220 nm处监测洗脱液。 Olmesartan Medoxomil和Metoprolol Succinate的保留时间分别为7.9分钟和4.1分钟。方法的线性，精密度，准确性，特异性，检出限和定量限均经过验证。结果：奥美沙坦美多索米和琥珀酸美托洛尔的线性和回收率均在5-35μg/ ml和100±分别为2％。在酸性，碱性，氧化，光稳定性和热降解（干热和湿热）条件下分别对药物及其混合物进行应力测试，并且从分析物峰中可以很好地分辨其降解产物。该方法已成功验证了准确性，精度和线性度。

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