Abstract
A new and accurate chiral HPLC method was developed for the determination of Melphalan HCl, L-Phenylalanine, 4-bis (2-chloroethyl) amino hydrochloride an anti-cancer chemotherapy drug and its potential impurity namely D-Phenylalanine, 4-bis (2-chloroethyl) amino hydrochloride ( D-enantiomer) in bulk substance. HPLC separation was carried out by reverse phase chromatography on Crownpak CR (+) (5μm, 4.0x150mm) with a mobile phase composed of perchloric acid (pH 4.0): methanol in the ratio of 90:10. Melphalan and its potential impurities were baseline resolved in the optimized method. The pH of perchloric acid solution in the mobile phase has played a key role in achieving chromatographic resolution between the enantiomers and in enhancing chromatographic efficiency. The developed method was completely validated and proved to be robust. The validated method yielded good results regarding specificity, precision, linearity, accuracy, robustness, sensitivity. Melphalan HCl sample solution is found to be stable for at least 60hrs at room temperature. The proposed method was found to be suitable and accurate for quantitative determination of Melphalan HCl and its D-enantiomer in bulk substance.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
