Challenges in the analytical method development and validation for an unstable active pharmaceutical ingredient

Journal of Chromatographic Science
Peter SajonzDavid Detora

Abstract

A sensitive high-performance liquid chromatography (HPLC) impurity profile method for the antibiotic ertapenem is developed and subsequently validated. The method utilizes an Inertsil phenyl column at ambient temperature, gradient elution with aqueous sodium phosphate buffer at pH 8, and acetonitrile as the mobile phase. The linearity, method precision, method ruggedness, limit of quantitation, and limit of detection of the impurity profile HPLC method are found to be satisfactory. The method is determined to be specific, as judged by resolving ertapenem from in-process impurities in crude samples and degradation products that arise from solid state thermal and light stress, acid, base, and oxidative stressed solutions. In addition, evidence is obtained by photodiode array detection studies that no degradate or impurity having a different UV spectrum coeluted with the major component in stressed or unstressed samples. The challenges during the development and validation of the method are discussed. The difficulties of analyzing an unstable active pharmaceutical ingredient (API) are addressed. Several major impurities/degradates of the API have very different UV response factors from the API. These impurities/degradates are synt...Continue Reading

Citations

Jun 14, 2013·Chemistry Central Journal·Judyta Cielecka-PiontekPiotr Garbacki
Feb 10, 2016·Critical Reviews in Analytical Chemistry·Tahisa Marcela Pedroso, Hérida Regina Nunes Salgado
Jul 2, 2014·Journal of Chromatographic Science·Judyta Cielecka-PiontekMagdalena Paczkowska
Jul 20, 2010·Annual Review of Analytical Chemistry·Peter Schoenmakers

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