Vinburnine (VNB) is a vinca alkaloid used as a vasodilator to enhance cerebral circulatory insufficiency. It is a cyclic amide containing drug which is expected to be sensitive to hydrolytic degradation. The degradation profile of VNB was studied in this work following ICH recommendations for stability study. The drug was sensitive only to degradation with NaOH with the formation of the carboxylic acid derivative, identified by IR and ¹H-NMR analyses as 2-((1S,12bS)-1-ethyl-1,2,3,4,6,7,12,12b-octahydroindolo[2,3-a] quinolizin-1-yl) acetic acid, (DEG). In this study five simple, smart and univariate stability indicating spectrophotometric methods were developed and validated for simultaneous determination of VNB and DEG for the first time. The developed methods include; Dual Wavelength Method (DWM), Dual Wavelength Resolution Method (DWRM), Factorized Absorbance Difference Method (FADM), Advanced Absorbance Subtraction Method (AASM), and Derivative Amplitude Factor Method (DAFM). These methods were capable of determination of VNB and DEG over the ranges of 1-30 and 3-50 µg/mL, respectively. The proposed methods were simple, smart, specific, and could be applied for analyzing synthetic mixtures of VNB and DEG and were successfully applied for determination of the drug in commercially available capsules. The obtained results of these methods were statistically compared with the reported HPLC one using student's-t and F- tests, where no significant difference was observed. Validation of the developed methods was applied according to ICH recommendations and all the results were within the acceptable limits.

长春花碱（VNB）是一种长春花生物碱，用作血管扩张剂，可增强脑循环功能不全。它是一种含环状酰胺的药物，预期对水解降解敏感。根据ICH关于稳定性研究的建议，在这项工作中研究了VNB的降解情况。该药物仅对用NaOH降解并形成羧酸衍生物敏感，由IR和¹鉴定。H-NMR分析为2-（（1S，12bS）-1-乙基-1,2,3,4,6,7,12,12b-八氢吲哚[2,3-a]喹啉锌-1-基）乙酸，（DEG）。在这项研究中，开发了五种简单，智能和单变量稳定性指示分光光度法，并首次验证了它们可同时测定VNB和DEG。开发的方法包括：双波长方法（DWM），双波长分辨率方法（DWRM），因式吸收率差法（FADM），高级吸收率减法（AASM）和微分振幅因子法（DAFM）。这些方法能够分别在1-30和3-50 µg / mL范围内测定VNB和DEG。提出的方法简单，智能，特定，可用于分析VNB和DEG的合成混合物，并已成功地用于测定市售胶囊中的药物。将这些方法获得的结果与使用s-t和F-检验的报道的HPLC进行统计学比较，结果未发现显着差异。根据ICH建议对开发的方法进行验证，所有结果均在可接受的范围内。