A Validated Chiral HPLC Method for the Enantiomeric Separation of Melphalan HCl

Li Ping Gao; Wen Juan Li; Xin Ping Wang

doi:10.4028/www.scientific.net/AMR.781-784.993

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HomeAdvanced Materials ResearchAdvanced Materials Research Vols. 781-784A Validated Chiral HPLC Method for the...

A Validated Chiral HPLC Method for the Enantiomeric Separation of Melphalan HCl

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.

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Periodical:

Advanced Materials Research (Volumes 781-784)

Pages:

993-998

DOI:

https://doi.org/10.4028/www.scientific.net/AMR.781-784.993

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Online since:

September 2013

Authors:

Li Ping Gao, Wen Juan Li, Xin Ping Wang

Keywords:

Chiral HPLC, Crownpak CR (+), Melphalan HcI, Validation

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References

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