A specific, accurate, precise, robust, and cost-effective HPLC method was developed and validated for quantitative analysis of Fimasartan Potassium Trihydrate and Cilnidipine in fixed-dose combination. The isocratic elution was accomplished by Symmetry C18 column (150 mm × 4.6 mm, 5 µm) at 25 °C. Mobile phase composition is Methanol: Acetonitrile: Potassium Dihydrogen Phosphate buffer (pH 3) (60:05:35%v/v/v) at a flow rate of 1.0 mL/min, injection volume 20 µL with DAD detection at 240 nm. Fimasartan Potassium Trihydrate and Cilnidipine were eluted with retention time 2.65 min and 5.51 min respectively. This method was validated as per ICH guideline (Q2 R1). The calibration plots were over the concentration range of 15–90 μg/mL and 2.5–15 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine with correlation coefficient 0.9992 and 0.9989 respectively. Accuracy was obtained between 99.51–101.65% and 100.06–101.20% for Fimasartan Potassium Trihydrate and Cilnidipine respectively. LOD were found to be 0.97 μg/mL and 0.57 μg/mL and LOQ were found to be 2.95 μg/mL and 1.75 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine respectively. The results showed that the developed method is reliable for the routine analysis for simultaneous determination of Fimasartan Potassium Trihydrate and Cilnidipine.

中文翻译：

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通过 HPLC 同时估计合成混合物中非马沙坦三水合钾和西尼地平治疗高血压 II 期的分析方法开发和验证

开发并验证了一种特定、准确、精确、稳健且经济高效的 HPLC 方法，用于定量分析非马沙坦三水合钾和西尼地平固定剂量组合。等度洗脱通过 Symmetry C18 柱（150 mm × 4.6 mm，5 µm）在 25 °C 下完成。流动相组成为甲醇：乙腈：磷酸二氢钾缓冲液（pH 3）（60:05:35%v/v/v），流速为 1.0 mL/min，进样体积 20 µL，DAD 检测波长为 240 nm。非马沙坦钾三水合物和西尼地平分别以 2.65 分钟和 5.51 分钟的保留时间洗脱。该方法已根据 ICH 指南 (Q2 R1) 进行验证。非马沙坦三水合钾和西尼地平的校准曲线在 15–90 μg/mL 和 2.5–15 μg/mL 的浓度范围内，相关系数为 0.9992 和 0。分别为 9989。非马沙坦三水合钾和西尼地平的准确度分别为 99.51-101.65% 和 100.06-101.20%。非马沙坦三水合钾和西尼地平的 LOD 分别为 0.97 μg/mL 和 0.57 μg/mL，LOQ 分别为 2.95 μg/mL 和 1.75 μg/mL。结果表明，所建立的方法对于同时测定非马沙坦三水合钾和西尼地平的常规分析是可靠的。