El-Bagary Ramzia I, Elkady Ehab F, Mowaka Shereen, Attallah Maria A
Cairo University, Faculty of Pharmacy, Pharmaceutical Chemistry Department, Kasr El-Aini St, Cairo 11562, Egypt.
British University in Egypt, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Sweis Rd, El-Sherouk City, Cairo 11837, Egypt.
J AOAC Int. 2017 Jul 1;100(4):992-999. doi: 10.5740/jaoacint.16-0279. Epub 2017 Feb 7.
A simple, accurate, and precise LC method with a reversed stationary phase was developed and validated for the determination of perindopril (PER) arginine, amlodipine (AML), and indapamide (IND) alone and in binary mixtures (PER arginine is found in two dosage forms, i.e., with either AML or IND). Chromatographic separation was carried out on a BDS Hypersil® C18 column (100 × 3 mm, 5 μm). The mobile phase, consisting of 0.05 M potassium dihydrogen phosphate buffer (pH 2.6)-methanol (50 + 50, v/v), was pumped through the column whose temperature was maintained at 50°C at a flow rate of 0.6 mL/min using isocratic elution, and UV detection at 215 nm was performed. Acceptable values of linearity, accuracy, and precision of the method were found over the concentration ranges of 5-80 μg/mL PER, 2.5-80 μg/mL AML, and 0.5-20 μg/mL IND. The proposed chromatographic method was statistically compared to that of reference methods using one-way analysis of variance. The results showed that there was no significant difference between the methods. The developed method proved reliable for use in accurate QC of the drugs in their pharmaceutical preparations.
开发并验证了一种简单、准确且精密的反相液相色谱法，用于单独测定培哚普利（PER）精氨酸、氨氯地平（AML）和吲达帕胺（IND），以及二元混合物中的这些成分（培哚普利精氨酸存在于两种剂型中，即与AML或IND联用）。色谱分离在BDS Hypersil® C18柱（100×3 mm，5μm）上进行。流动相由0.05 M磷酸二氢钾缓冲液（pH 2.6）-甲醇（50 + 50，v/v）组成，以等度洗脱方式以0.6 mL/min的流速泵入温度保持在50°C的色谱柱，并在215 nm处进行紫外检测。在5 - 80μg/mL PER、2.5 - 80μg/mL AML和0.5 - 20μg/mL IND的浓度范围内，该方法的线性、准确度和精密度值均可接受。使用单向方差分析将所提出的色谱方法与参考方法进行统计学比较。结果表明，这些方法之间没有显著差异。所开发的方法被证明可可靠地用于药物制剂中药物的准确质量控制。
