Validation of a quantitative HPLC method for bacitracin and bacitracin zinc using EDTA as a mobile-phase modifier.
作者： Alan R. Potts , Tatiana Psurek , Cassandra Jones , Luba Parris , Ahalya Wise
DOI: 10.1016/J.JPBA.2012.06.016
关键词:
摘要: Abstract Any product marketed in the United States and labeled bacitracin must comply with tests, procedures, acceptance criteria relevant monograph published US Pharmacopeia (USP). The test procedure relies on accurate recovery of Bacitracin A many other components. authors determined that current USP does not recover at low concentration levels. They postulate this is result bacitracin's known ability to chelate metal ions, e.g. bacitracin–zinc complexes. Thus ubiquitous ions HPLC systems may be responsible for sequestering giving recoveries. Addition edetate disodium (EDTA) mobile phase improved recovery. method validation results include precision, accuracy, linearity, specificity, robustness.
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