反相高效液相色谱法测定制剂中琥珀酸美托洛尔和奥美沙坦美多索米的含量及强制降解研究

T. Kumar, Samata Samantaray, D. Sankar
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引用次数: 2

摘要

建立了一种简便、特异、准确、精确的反相高效液相色谱(RP-HPLC)方法,用于同时测定琥珀酸美托洛尔和奥美沙坦美多索米制剂中的含量,并进行了强制降解研究。方法采用Enable C 18G色谱柱(250 ×4.6 mm, 5 μm),流动相为甲醇和水(pH调节至3.5),正磷酸,比例为80:20% v/v,流速为1 mL/min。紫外检测波长为240 nm。琥珀酸美托洛尔和美索米尔奥美沙坦的滞留时间分别为3.986 min和6.092 min。对该方法进行了线性度、量程、准确度、精密度、鲁棒性、定量限和定量限的验证。琥珀酸美托洛尔在4 ~ 40 μg/mL (r2 = 0.9999)和奥美沙坦在5 ~ 60 μg/mL (r2 = 0.9999)范围内呈线性关系。琥珀酸美托洛尔日内精密度和日间精密度的% RSD分别为0.57和0.68,奥美沙坦美多索米的% RSD分别为0.52和0.41。琥珀酸美托洛尔的LOD和LOQ分别为0.1143 μg/mL和0.3565 μg/mL,奥美沙坦的LOD和LOQ分别为0.0563和0.1782 μg/mL。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Rp-Hplc Method for Estimation of Metoprolol Succinate and Olmesartan Medoxomil in Pharmaceutical Formulation with forced Degradation Studies
A simple, specific, accurate, and precise RP-HPLC method was developed and validated for the simultaneous estimation of Metoprolol Succinate and Olmesartan Medoxomil in pharmaceutical formulation with forced degradation studies. The method was developed using Enable C 18G column (250 ×4.6 mm, 5 μm) with mobile phase consisting of methanol and water (pH adjusted to 3.5 with orthophosphoric acid in the ratio of 80: 20 % v/v with a flow rate of 1 mL/min. The UV detection was carried out at 240 nm. The retention time for Metoprolol Succinate and Olmesartan Medoxomil were found to be 3.986 and 6.092 min, respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD, and LOQ. Linearity was observed over a concentration range 4-40 μg/mL for Metoprolol Succinate (r2 = 0.9999) and 5-60 μg/ml for Olmesartan Medoxomil (r2 = 0.9999). The % RSD for Intraday and Interday precision was found to be 0.57 and 0.68 for Metoprolol Succinate and 0.52 and 0.41 for Olmesartan Medoxomil. The LOD and LOQ were found to be 0.1143 μg/mL and 0.3565 μg/mL for Metoprolol Succinate and LOD and LOQ were found to be 0.0563 and 0.1782 μg/mL for Olmesartan Medoxomil respectively.
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