Optical Radiation Standards, National Physical Laboratory, Council of Scientific and Industrial Research, KS Krishnan Road, New Delhi 110012, India.
J Pharm Biomed Anal. 2010 Nov 2;53(3):287-94. doi: 10.1016/j.jpba.2010.03.030. Epub 2010 Mar 30.
Nelfinavir mesylate is the first nonpeptidic protease inhibitor available in pediatric formulation. In the present paper the stability of nelfinavir mesylate under different stress conditions is evaluated using Fourier transform infrared spectroscopy. The drug is subjected to thermal degradation, photodegradation, acid hydrolysis, base hydrolysis and oxidation as per ICH guidelines. Differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray diffraction (XRD) and high performance liquid chromatography (HPLC) are carried out to support the implementation of infrared spectroscopy for the stability studies of nelfinavir mesylate. Significant changes are observed in the IR spectra collected after exposing the drug to thermal radiations, acid and base hydrolysis and oxidative degradation. No change is observed in the spectra of the drug after exposing it to sunlight indicating the good photostability of nelfinavir mesylate. The results of infrared spectroscopy agree well with that of other complementary techniques as DSC, TGA, XRD and HPLC.
奈非那韦甲磺酸盐是第一种可供儿科配方使用的非肽类蛋白酶抑制剂。本文采用傅里叶变换红外光谱法评价了奈非那韦甲磺酸盐在不同应激条件下的稳定性。根据 ICH 指南，药物经受热降解、光降解、酸水解、碱水解和氧化。差示扫描量热法（DSC）、热重分析（TGA）、X 射线衍射（XRD）和高效液相色谱（HPLC）用于支持红外光谱在奈非那韦甲磺酸盐稳定性研究中的应用。在将药物暴露于热辐射、酸和碱水解以及氧化降解后，收集到的 IR 光谱中观察到明显的变化。将药物暴露于阳光下后，其光谱没有变化，表明奈非那韦甲磺酸盐具有良好的光稳定性。红外光谱的结果与其他补充技术（如 DSC、TGA、XRD 和 HPLC）的结果吻合良好。
