In an article, author is Noorbasha, Khaleel, once mentioned the application of 130307-08-3, Name is 1-(4-Bromophenyl)-4-methylpiperazine, molecular formula is C11H15BrN2, molecular weight is 255.1542, MDL number is MFCD09029689, category is piperazines. Now introduce a scientific discovery about this category, Quality Control of 1-(4-Bromophenyl)-4-methylpiperazine.
Determination of residual solvents in paclitaxel by headspace gas chromatography
Background: A simple and sensitive gas chromatographic method was developed and validated for the simultaneous determination of methanol, ethanol, acetone, isopropyl alcohol, dichloromethane, N-hexane, ethyl acetate, tetrahydrofuran, and N,N-diisopropyl ethyl amine in Paclitaxel. A chromatographic separation was done on DB-624 column, 30m length x0.53mm ID, and film thickness 3 mu m, using a flame ionization detector (FID) with gradient column oven temperature program. The injection was carried out in split mode, with a split ratio of 5:1. A mixture of N-methyl-2-pyrrolidinone (contains 1% piperazine) and water in the ratio of 80:20 (v/v) was selected as a diluent to obtain good sensitivity along with the recovery. Results: The developed gas chromatographic method offers symmetric peak shape, good resolution of more than 2.0 between the solvent peaks, and the relative standard deviation for replicate injections of all the solvents were found to be not more than 15.0% with reasonable retention time for all the solvents. The limit of detection for methanol, ethanol, acetone, isopropyl alcohol, dichloromethane, N-hexane, ethyl acetate, tetrahydrofuran, and N,N-diisopropyl ethyl amine was found to be 304.69ppm, 497.98ppm, 498.99ppm, 504.49ppm, 61.81ppm, 30.07ppm, 505ppm, 73.05ppm, and 2.09ppm, respectively. Limit of quantitation of methanol, ethanol, acetone, isopropyl alcohol, dichloromethane, N-hexane, ethyl acetate, tetrahydrofuran, and N,N-diisopropyl ethyl amine was found to be 89.62ppm, 146.47ppm, 146.76ppm, 148.38ppm, 18.18ppm, 8.84ppm, 148.53ppm, 21.49ppm, and 0.62ppm, respectively. Precision was found to be satisfactory. Linear in the range of LOQ to 150% level for all the solvents, and accuracy along with robustness, is performed, and acceptable results were obtained. Conclusion: The proposed method was demonstrated to be simple, sensitive, specific, linear, precise, accurate, and robust, hence can be used to determine the residual organic solvents in Paclitaxel drug substance and drug product.
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Reference:
Piperazine – Wikipedia,
,Piperazines – an overview | ScienceDirect Topics