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Abstract：
The fixed-dose combination of Amlodipine Besylate (ADB) with Perindopril Tertbutylamine (PTBA) drug is used to treat patients with mild-to-moderate hypertension. In recent times researchers are interested to find the efficient analytical method development and validation for the simultaneous determination of ADB and PTBA in a fixed-dose, film-coated tablet. Therefore, the current study was performed with a reverse-phase liquid chromatography method developed to simultaneously analyze ADB and PTBA in film-coated tablets as fixed-dose combinations. The linearity of the proposed method was calculated by preparing six different mixtures of both ADB and PTBA in the mobile phase. The concentration of both the analytes was analyzed at 56mg/100 mL to 84mg/100 mL and 32mg/100 mL to 48mg/100 mL, respectively. The ratio of acetonitrile and phosphate buffer was 35:65. The flow rate was adjusted to 1.5 ml per minute to reduce the retention time. The validation study was performed for the parameters specificity, linearity, precision, range, limit of detection, limit of quantification, accuracy/biasness, and robustness. The relative percentage standard deviation for Perindopril Tertbutyl amine was 0.148%, and for Amlodipine is 0.312%. These results show that the advanced analysis method for simultaneous analysis of fixed-dose is precise. The theoretical IR spectra were also calculated by Gaussian 9.2 by employing the B3LYP functional at density functional theory (DFT) level study. All these parameters studied in this work authenticate the effectiveness of the developed validation method and ensure its repeatability/reproducibility accordingly. To the best of our knowledge, this is the first time to develop a new fast, and easy method for simultaneous identification and quantification of ADB and PTBA by high-performance liquid chromatography (HPLC) with a time-efficient and cost-effective approach.
摘要：
苯磺酸氨氯地平（ADB）与培林普利特丁胺（PTBA）药物的固定剂量组合用于治疗轻度至中度高血压患者。近年来，研究人员有兴趣寻找有效的分析方法开发和验证，以同时确定固定剂量的ADB和PTBA，薄膜包衣片。因此,本研究采用反相液相色谱法进行,该方法旨在同时分析固定剂量组合的薄膜包衣片剂中的ADB和PTBA.通过在流动相中制备ADB和PTBA的六种不同混合物来计算所提出方法的线性。分析两种分析物的浓度分别为56mg/100mL至84mg/100mL和32mg/100mL至48mg/100mL，分别。乙腈和磷酸盐缓冲液的比例为35:65。将流速调节至1.5ml/分钟以减少保留时间。对参数特异性进行了验证研究，线性度精度,范围,检测限，定量极限，精度/偏度，和鲁棒性。培多普利特丁胺的相对百分比标准偏差为0.148%，氨氯地平为0.312%。这些结果表明，同时分析固定剂量的高级分析方法是精确的。通过采用密度泛函理论（DFT）水平的B3LYP泛函研究，还通过高斯9.2计算了理论IR光谱。在这项工作中研究的所有这些参数都验证了所开发的验证方法的有效性，并相应地确保了其可重复性/再现性。据我们所知,这是第一次开发新的快速，以及通过高效液相色谱（HPLC）以省时且经济有效的方法同时鉴定和定量ADB和PTBA的简便方法。
