The use of liquid chromatography-mass spectrometry for the identification of drug degradation products in pharmaceutical formulations.
Recent applications of LC-MS in the analysis of drug degradation products in pharmaceutical formulations are reviewed. Drug degradation products are categorized according to their formation mechanism: oxidation, hydrolysis, dimerization and adduct formation with excipients and packaging materials. The oxidative ring opening and dimerization of an indole derivative are discussed in detail. The examples used in this review clearly demonstrate that LC-MS is a very powerful technique for the analysis of low-level degradates in formulations without the time-consuming isolation process. At the same time, limitations and precaution of using LC-MS techniques for unknown identification are also addressed. In some cases, the LC-MS data could become misleading if the ionization process and gas-phase behavior of the analytes are not well understood.
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Department of Pharmaceutical Research and Development, Merck Research Laboratories, P. O. Box 4, West Point, PA 19486, USA.
D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid / Q000379:methods*; D019281:Dimerization; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry; D006868:Hydrolysis; D013058:Mass Spectrometry / Q000379:methods*; D010084:Oxidation-Reduction; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry
D005079:Excipients; D004364:Pharmaceutical Preparations