Application of HPLC with ELSD detection for the assessment of azelaic acid impurities in liposomal formulation.
In the course of research and development of a new pharmaceutical formulation of azelaic acid in the liposomal form, we developed a rapid and accurate method for the detection of impurities using high-performance liquid chromatography. A chromatographic column from Merck (Purospher Star RP C18, 250-4 mm (5 μm) was used in the assay, and the mobile phase gradient consisted of three phases: A--methanol : water (5 : 95) + 1.5% (v/v) acetic acid; B--water : methanol (5 : 95) + 1.5% (v/v) acetic acid; and C--chloroform. Detection of the impurities and the active substance was performed by an evaporative light-scattering detector. The method was validated for selectivity, system precision, method precision, limit of detection, and response rates. The proposed method can be used to detect impurities in the liposomal formulation of azelaic acid. The method enables separation of azelaic acid from the identified and unidentified impurities and from the excipients used in the drug form.
Department of Industrial Pharmacy, Wroclaw Medical University, Borowska Street 211A, 50-556 Wroclaw, Poland.
Stanislaw
S
Han
Katarzyna
K
Karlowicz-Bodalska
Dorota
D
Szura
Lukasz
L
Ozimek
Witold
W
Musial
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003879:Dermatologic Agents / Q000032:analysis; D003998:Dicarboxylic Acids / Q000032:analysis* / Q000737:chemistry; D004340:Drug Contamination; D008027:Light; D057230:Limit of Detection; D008081:Liposomes / Q000737:chemistry*; D012542:Scattering, Radiation
D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; D008081:Liposomes; C010038:azelaic acid