Khan Muhammad Farooq Saleem, Tahir Lutafullah, Zhou Xu, Bary Ghulam, Sajid Muhammad, Shahzad Ahmad Khawar, Khan Ilyas, Mohamed Abdullah, Ahmad Riaz
Faculty of International Applied Technology, Yibin University, Yibin 644000, Sichuan China.
Department of Chemistry Minhaj University, Lahore Pakistan.
Heliyon. 2023 Mar 1;9(3):e14209. doi: 10.1016/j.heliyon.2023.e14209. eCollection 2023 Mar.
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.
苯磺酸氨氯地平（ADB）与培哚普利叔丁胺（PTBA）的固定剂量复方制剂用于治疗轻至中度高血压患者。近年来，研究人员致力于开发高效的分析方法，并对固定剂量薄膜包衣片中ADB和PTBA的同时测定进行验证。因此，本研究采用反相液相色谱法，用于同时分析薄膜包衣片中作为固定剂量复方制剂的ADB和PTBA。通过在流动相中制备六种不同的ADB和PTBA混合物来计算所提出方法的线性。两种分析物的浓度分别在56mg/100 mL至84mg/100 mL和32mg/100 mL至48mg/100 mL范围内进行分析。乙腈与磷酸盐缓冲液的比例为35:65。流速调整为每分钟1.5 mL以缩短保留时间。对特异性、线性、精密度、范围、检测限、定量限、准确度/偏差和稳健性等参数进行了验证研究。培哚普利叔丁胺的相对标准偏差百分比为0.148%，氨氯地平为0.312%。这些结果表明，用于同时分析固定剂量的先进分析方法是精确的。还通过高斯9.2在密度泛函理论（DFT）水平研究中采用B3LYP泛函计算了理论红外光谱。本工作中研究的所有这些参数证实了所开发验证方法的有效性，并相应地确保了其可重复性/再现性。据我们所知，这是首次开发一种新的快速、简便的方法，通过高效液相色谱（HPLC）以省时且经济高效的方式同时鉴定和定量ADB和PTBA。
