Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, 62514 Beni-Suef, Egypt.
Analytical Toxicology Laboratory, Forensic Medicine Authority, Ministry of Justice, 11647 Cairo, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2019 May 5;214:21-31. doi: 10.1016/j.saa.2019.01.080. Epub 2019 Jan 28.
A stressed study on the stability and degradation behavior under ICH forced degradation conditions of most widely used antiepileptic drug; carbamazepine (CMZ) is presented in this work. The research also includes studying spectrophotometric nature of CMZ and assaying it with mostly used spectrophotometric techniques. Six simple and sensitive spectrophotometric methods are introduced as stability indicating methods for quantitative determination of CMZ and its degradation product, one of its reported potential impurities; iminostilbene (IMS). Dual wavelength is method I where two wavelengths (215 and 270 nm for CMZ and 258 and 307 nm for IMS) were chosen for each component while absorbance difference is zero for the second one. Method II is isoabsorptive point method where the absorbance of CMZ at A was measured in the range of 0.5-20 μg mL. Method III is second derivative method which allows simultaneous determination of CMZ at 247 nm and IMS at 273 nm without any interference. Method IV based on measuring the peak amplitude of first derivative of ratio spectra (DD) at 280.5 and 253 nm for determination of CMZ and IMS, respectively. Method V is mean centering of the ratio spectra with good linearity for CMZ and IMS over 200-330 nm. Ratio difference method is method VI where good linearity was achieved for determination of CMZ and IMS by measuring differences in the amplitude of ratio spectra at 285, 258 nm and 258, 285 nm, respectively. The proposed methods show successful application in CMZ's pharmaceutical formulations.
本工作研究了最广泛使用的抗癫痫药物卡马西平(CMZ)在 ICH 强制降解条件下的稳定性和降解行为。还研究了 CMZ 的分光光度性质,并使用最常用的分光光度技术对其进行了测定。介绍了六种简单灵敏的分光光度法,作为 CMZ 及其降解产物(一种已报道的潜在杂质亚氨基苯乙烯(IMS)的定量测定的稳定性指示方法。双波长法 I 选择了两个波长(CMZ 的 215 和 270nm 以及 IMS 的 258 和 307nm),对于第二个波长,吸光度差为零。等吸收点法 II 是在 0.5-20μg/mL 范围内测量 CMZ 在 A 处的吸光度。第二衍生物法 III 允许在没有任何干扰的情况下同时测定 CMZ 在 247nm 和 IMS 在 273nm 的含量。基于比率光谱(DD)的一阶导数的峰幅度测量的方法 IV(DD),分别用于测定 CMZ 和 IMS,在 280.5nm 和 253nm 处。比率光谱的均值中心化法 V 对于 CMZ 和 IMS 在 200-330nm 范围内具有良好的线性关系。比率差法 VI 是通过分别在 285nm、258nm 和 258nm、285nm 处测量比率光谱的幅度差,实现了 CMZ 和 IMS 的良好线性测定。所提出的方法成功应用于 CMZ 的药物制剂。