title: Validation of direct assay of an aqueous formulation of a drug compound AZY by chiral supercritical fluid chromatography (SFC).
abstract: Supercritical fluid chromatography (SFC) is increasingly being recognized as a powerful technique for analysis of pharmaceutical compounds in various dosage forms. Assay of aqueous formulations of research compounds by SFC is, however, a relatively unexplored area primarily due to the potential problems associated with it. This work describes the development of a direct assay of a chiral drug compound AZY in a 100% aqueous formulation by SFC, and its qualification following ICH and FDA validation guidelines on chromatographic methods. The results indicated that SFC has the potential for assaying aqueous formulations of research compounds with high degree of selectivity, accuracy, precision, robustness, sensitivity, and linearity over a wide range of concentrations. This work also confirmed a previous hypothesis that direct formulation assay by SFC approach is applicable to both acidic and basic pharmaceutical compounds with equal degree of success.
authors.affiliation: Early Development, Pharmaceutical and Analytical R and D, AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, USA. Partha.Mukherjee@astrazeneca.com
authors.forename: Partha S
authors.initials: PS
authors.lastname: Mukherjee
mesh_terms: D000688:Amylose / Q000031:analogs & derivatives / Q000737:chemistry; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D025924:Chromatography, Supercritical Fluid / Q000379:methods* / Q000592:standards; D004355:Drug Stability; D017408:Guidelines as Topic; D016018:Least-Squares Analysis; D016014:Linear Models; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D048448:Phenylcarbamates / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012996:Solutions; D013237:Stereoisomerism; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations; D048448:Phenylcarbamates; D012996:Solutions; C080033:Chiralpak AD; D000688:Amylose