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首页> 外文期刊>American Journal of Analytical Chemistry >Stress Degradation Behavior of a Polypill and Development of Stability Indicating UHPLC Method for the Simultaneous Estimation of Aspirin, Atorvastatin, Ramipril and Metoprolol Succinate
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Stress Degradation Behavior of a Polypill and Development of Stability Indicating UHPLC Method for the Simultaneous Estimation of Aspirin, Atorvastatin, Ramipril and Metoprolol Succinate

机译：同时估计阿司匹林，阿托伐他汀，雷米普利和琥珀酸美托洛尔的多药丸的应力降解行为和稳定性的UHPLC方法开发

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摘要

A novel, sensitive and precise UHPLC method has been developed and validated for the simultaneous determination of the all the active components of a Polypill viz Zycad, i.e., Aspirin (ASP) Atorvastatin (ATV), Ramipril (RMP) and Metoprolol (MTP) in Zycad tablet dosage form in the presence of degradation products. Forced degradation of individual as well as combination of all the drug substances components of Polypill was conducted in accordance with ICH guidelines. Acidic, basic, neutral, and oxidative hydrolysis, thermal stress, and photolytic degradation were used to assess the stability-indicating power of the method. Use of 100 × 2.1 mm, 1.7 μm stationary phases with simple mobile phase combination buffer consisting of 0.1% Perchloric acid (adjusted to pH 2.5) and Acetonitrile, delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 215 nm with a flow rate of 0.6 mL?min–1. The method was optimized using samples generated by forced degradation studies. The method was validated for linearity, accuracy (recovery), precision, Specificity and robustness. The method was linear in the range of 37.5 to 150.0 μg?mL–1 for ASP, 5.0 to 20.0 μg?mL–1 for ATV and 2.5 to 10.0 μg?mL–1 for RMP and 25.0 to 100.0 μg?mL–1 for MTP.
机译：开发了一种新颖，灵敏，精确的UHPLC方法，并已验证了该方法可同时测定Polypill viz Zycad的所有活性成分，即阿司匹林（ASP）阿托伐他汀（ATV），雷米普利（RMP）和美托洛尔（MTP）。 Zycad片剂在降解产物存在下的剂型。按照ICH指南对Polypill的所有药物成分进行单独降解以及所有药物成分进行联合降解。使用酸性，碱性，中性和氧化水解，热应力和光解降解来评估该方法的稳定性指标。使用100×2.1 mm，1.7μm固定相以及由0.1％高氯酸（调节至pH 2.5）和乙腈组成的简单流动相组合缓冲液，以梯度模式提供，并使用215 nm紫外检测器进行定量流速为0.6 mL？min-1。使用强制降解研究产生的样品对方法进行了优化。该方法的线性，准确性（回收率），精密度，特异性和鲁棒性均得到验证。该方法在ASP的37.5至150.0μg？mL–1，ATV在5.0至20.0μg？mL–1，RMP在2.5至10.0μg？mL–1和25.0至100.0μg？mL–1的范围内是线性的MTP。

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