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用于同时定量原料药和片剂制剂中抗高血压药物的绿色振动光谱法。

Green vibrational spectroscopic approach for simultaneous quantification of antihypertensive drugs in bulk and tablet formulations.

作者信息

K Naga Prashant, Yenduri Suvarna

机构信息

Faculty of Pharmacy, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, India.

出版信息

Sci Rep. 2025 Apr 16;15(1):13097. doi: 10.1038/s41598-025-97485-3.

Abstract

The selection of IR spectroscopic approach for quantification of drugs supports green analytical chemistry principles without compromising the method analytical performance. The method follows pressed pellet technique for preparing samples using potassium bromide without using any toxic solvents and even reduced waste too. An easy, fast, and environmentally friendly FT-IR spectrophotometric method was developed and validated for the simultaneous measurement of amlodipine besylate (AML) and telmisartan (TEL) in pharmaceutical combination formulations. The absorbance spectra which was obtained from obtained transmittance spectra were used for determining area under curve and correlated with amount or concentration. AML and TEL shows peaks at 1206 cm and 863 cm. Validation of the developed method followed ICH guidelines and all the validation results were within the limits. The LOD and LOQ of AML were found as 0.009359 %w/w, 0.028359 %w/w respectively where for TEL it was found to be 0.008241 %w/w and 0.024974 %w/w respectively. The MoGAPI, AGREE prep, and RGB model assessment procedure was green and sustainable. The described HPLC technique was not significantly different statistically.

摘要

选择红外光谱法对药物进行定量分析,既支持绿色分析化学原则,又不影响方法的分析性能。该方法采用压片技术,使用溴化钾制备样品,不使用任何有毒溶剂,甚至还减少了废弃物。开发并验证了一种简便、快速且环保的傅里叶变换红外分光光度法,用于同时测定药物复方制剂中苯磺酸氨氯地平(AML)和替米沙坦(TEL)的含量。从所得透射光谱获得的吸收光谱用于确定曲线下面积,并与含量或浓度相关联。AML和TEL分别在1206 cm和863 cm处显示出峰。所开发方法的验证遵循国际协调会议(ICH)指南,所有验证结果均在规定范围内。AML的检测限(LOD)和定量限(LOQ)分别为0.009359 %w/w、0.028359 %w/w,而TEL的检测限和定量限分别为0.008241 %w/w和0.024974 %w/w。MoGAPI、AGREE prep和RGB模型评估程序具有绿色可持续性。所描述的高效液相色谱技术在统计学上没有显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e3c6/12003683/111912422d6d/41598_2025_97485_Fig7_HTML.jpg

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