We report expedient methods to analyze the inactive and active ingredients and other impurities in Fulvestrant injection, using gas chromatography and high-performance liquid chromatography. The levels (LOQ to 150%) of Fulvestrant and related impurities were quantified using HPLC. A gradient temperature program was employed to reduce the analysis time and improve the peaks' resolution in the present study. The separation of impurities was achieved on the symmetry C8 column and maintained temp at 35 °C. The injection volume was 10 µL, and detection was made at 225 nm. For GC method used the DB-Wax column. Helium as a carrier with a flow rate of 5.0 mL min⁻¹. The injector inlet temperature and FID temperature were maintained at 220 °C and 280 °C, respectively. Both methods exhibited excellent intra- and inter-day precision, with RSD < 2%, and a linear relationship was established between the concentration and detector response over a range of 50–150% of the target concentrations with R² > 0.999. The methods were validated for linearity, precision, specificity, accuracy, and robustness for their intended purpose as per the current ICH guidelines. Finally, both the techniques were used in the quality control lab to estimate the solvents and impurities of reference listed drug and in house samples.

我们报告了使用气相色谱法和高效液相色谱法分析氟韦斯特酯注射液中非活性和活性成分以及其他杂质的简便方法。使用高效液相色谱法测定了氟韦斯特能和相关杂质的含量（LOQ至150％）。在本研究中，采用了梯度温度程序来减少分析时间并提高峰的分离度。在对称C8色谱柱上实现了杂质分离，并将温度保持在35°C。进样量为10 µL，在225 nm处进行检测。对于GC方法，使用DB-Wax列。氦气作为载体，流速为5.0 mL min ^-1。进样器入口温度和FID温度分别保持在220°C和280°C。两种方法均表现出出色的日内和日间精度，RSD <2％，并且浓度和检测器响应在目标浓度的50–150％范围内建立了线性关系，R ²  > 0.999。根据当前的ICH指南，针对预期目的对方法进行了线性，精密度，特异性，准确性和鲁棒性验证。最终，这两种技术都在质量控制实验室中用于估计参考所列药物和内部样品中的溶剂和杂质。