Iqbal Muzaffar, Haq Nazrul, Kalam Mohd Abul, Imam Faisal, Shakeel Faiyaz
Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
ACS Omega. 2024 May 16;9(21):23101-23110. doi: 10.1021/acsomega.4c03976. eCollection 2024 May 28.
The orexin receptor antagonist (ORA) is one of the new psychopharmacological agents used in the treatment of insomnia. There are currently no documented greener high-performance liquid chromatography-diode array detector (HPLC-DAD) methods for the analysis of ORA antagonists, lemborexant (LMB) and suvorexant (SUV) simultaneously. Therefore, in this study, a simple, sensitive, and greener HPLC-DAD method has been developed for the simultaneous quantitative analysis of LMB and SUV in bulk and laboratory-prepared mixture. The developed method was validated for numerous validation parameters and evaluated for greenness. The C Waters Spherisorb CN (4.6 × 250 mm; 5 μm) column was used for the chromatographic separation. The mobile phase composition was ethanol: 10 mM KHPO buffer in a ratio of (60:40 v/v). The DAD detection was performed at 253 nm using a Waters DAD detector. The greenness was evaluated using the analytical Eco-Scale (AES), ChlorTox, and analytical GREEnness (AGREE) techniques. The calibration curves showed excellent linearity for LMB and SUV between the concentration range of 125-5000 ng/mL and 250-10,000 ng/mL, respectively. In addition, the proposed HPLC-DAD method was accurate, precise, robust, highly sensitive, and greener. AES, ChlorTox, and AGREE scales were predicted by the HPLC-DAD method to be 91, 1.14 g, and 0.79, respectively, showing an excellent greenness profile. The greener HPLC-DAD method was successfully used to analyze both medicines quantitatively in bulk and laboratory-prepared synthetic mixtures. The findings of this study indicated that the proposed HPLC-DAD method may be consistently applied to evaluate LMB and SUV in bulk and dosage forms.
食欲素受体拮抗剂（ORA）是用于治疗失眠的新型精神药理学药物之一。目前尚无关于同时分析ORA拮抗剂、伦博瑞生（LMB）和苏沃雷生（SUV）的更环保高效液相色谱 - 二极管阵列检测器（HPLC - DAD）方法的文献记载。因此，在本研究中，已开发出一种简单、灵敏且更环保的HPLC - DAD方法，用于同时定量分析原料药及实验室制备混合物中的LMB和SUV。所开发的方法针对众多验证参数进行了验证，并对其绿色度进行了评估。采用沃特世Spherisorb CN（4.6×250 mm；5μm）色谱柱进行色谱分离。流动相组成为乙醇与10 mM磷酸二氢钾缓冲液，比例为（60:40 v/v）。使用沃特世DAD检测器在253 nm处进行DAD检测。采用分析生态量表（AES）、ChlorTox和分析绿色度（AGREE）技术评估绿色度。校准曲线显示，LMB和SUV在浓度范围分别为125 - 5000 ng/mL和250 - 10,000 ng/mL之间具有出色的线性关系。此外，所提出的HPLC - DAD方法准确、精密、稳健、高度灵敏且更环保。通过HPLC - DAD方法预测，AES、ChlorTox和AGREE量表分别为91、1.14 g和0.79，显示出出色的绿色度特征。所开发的更环保的HPLC - DAD方法成功用于定量分析原料药及实验室制备的合成混合物中的两种药物。本研究结果表明，所提出的HPLC - DAD方法可始终如一地应用于评估原料药及剂型中的LMB和SUV。
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