Quantitative estimation of Fulvestrant injection 505(j) composition and impurities profile by capillary gas chromatography and HPLC-PDA techniques

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 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.