Stability Indicating RP-HPLC Method by QbD Approach and LC-MS Characterization of Degradation Products of Mifepristone.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of chromatographic science Pub Date : 2025-03-27 DOI:10.1093/chromsci/bmaf017

Chandni Chandarana, Isha Juwarwala, Parixit Prajapati, Jaimin Kumar Patel

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引用次数: 0

Abstract

A Stability indicating revered phase high performance liquid chromatography (RP-HPLC) method have been developed and validated for the estimation of Mifepristone. LC-MS Studies was carried out for identification of possible degradation products. A simple, rapid, accurate and precise stability indicating RP-HPLC method was developed for quantification of Mifepristone. The developed method used the mixture of methanol and water (88:12 v/v) as mobile phase at flow rate of 1 ml /min, which was optimized with the help of Quality by Design approach. Detection was carried out at 305 mm. The linearity of the proposed method was found in the concentration range of 5-25 μg/ml with regression coefficient (R2) of 0.996. LOD and LOQ were found to be 0.0324 and 0.0982 μg/ml, respectively. The recovery of the proposed method was found to be 98%-100%. The method was found to be precise and robust. The developed stability indicating RP-HPLC method was successfully applied for quantification of Mifepristone in pharmaceutical dosage form. The degradation products were characterized by LC-MS and the fragmentation pathways were proposed.

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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.