Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Nasr City, Cairo 11751, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Damanhour University, Damanhour City, Beheira 22511, Egypt.
J AOAC Int. 2022 Jun 29;105(4):1200-1204. doi: 10.1093/jaoacint/qsac018.
Two fixed-dose combination tablets of amlodipine (AML) with bisoprolol (BIS) and amlodipine with candesartan (CAN) were recently approved for the treatment of hypertension.
Three UV spectrophotometric analytical methods were developed for the estimation of the above drugs in their combination mixtures.
For the AML and BIS mixture, AML was quantified directly by a zero-order spectrophotometric method at 360 nm without interference from BIS, whereas BIS was quantified by the ratio difference (RD) spectrophotometric method by calculating the difference between the amplitude values of the ratio spectra at 226 and 215 nm. For the AML and CAN mixture, AML was quantified directly by a zero-order spectrophotometric method at 360 nm without interference from CAN, whereas CAN was quantified by the first derivative of ratio spectra method by measuring the amplitude values of the derived spectra at 259 nm.BIS).
The proposed methods were successfully applied for quantitative analysis of AML with BIS and AML with CAN in their synthetic laboratory-prepared mixtures and pharmaceutical tablets with acceptable results in terms of accuracy and precision.
Simple, accurate, and environmentally friendly spectrophotometric methods were described for selective determination of the investigated drugs in their fixed-dose combinations.
最近批准了两种氨氯地平（AML）与比索洛尔（BIS）和氨氯地平与坎地沙坦（CAN）的固定剂量复方片剂，用于治疗高血压。
开发了三种紫外分光光度分析方法，用于测定上述药物在其组合混合物中的含量。
对于 AML 和 BIS 混合物，AML 通过零阶分光光度法在 360nm 处直接定量，不受 BIS 的干扰，而 BIS 通过比率差（RD）分光光度法通过计算在 226 和 215nm 处比值光谱的振幅值之间的差异来定量。对于 AML 和 CAN 混合物，AML 通过零阶分光光度法在 360nm 处直接定量，不受 CAN 的干扰，而 CAN 通过测定导数光谱在 259nm 处的振幅值来定量。
所提出的方法成功地应用于合成实验室制备的混合物和药用片剂中 AML 与 BIS 和 AML 与 CAN 的定量分析，在准确性和精密度方面均获得可接受的结果。
描述了简单、准确和环保的分光光度法，用于选择性测定固定剂量组合中研究药物的含量。
