Development, cross-validation and greenness assessment of capillary electrophoresis method for determination of ALP in pharmaceutical dosage forms - an alternative to liquid chromatography.

ABSTRACT: Breast cancer treatment has made tremendous progress in recent years and new therapies are emerging continuously. Alpelisib (ALP) is a novel phosphoinositide-3-kinase (PI3K) inhibitor recently approved for human receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated metastatic breast cancer in combination with fulvestrant. ALP has been the subject of only a limited number of preclinical in vitro and in vivo studies using different chromatographic techniques. However, no research has been published on analyzing ALP using capillary electrophoresis (CE). The absence of pharmacopoeial monographs for ALP in both the European and United States Pharmacopoeias highlights the urgent need to develop a reliable analytical method for its quality control in b

SUBMITTER: Mlinaric Z 

PROVIDER: S-EPMC11487321 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature