title: Determination of sodium metabisulfite in parenteral formulations by HPIC with suppressed conductivity detection.
abstract: Sulfurous compounds: sodium sulfite Na2SO3 (E 221), sodium bisulfite NaHSO, (E 222), and sodium metabisulfite Na2S2O5 (E 223) are largely used as antioxidants in many pharmaceutical formulations. A method for determination of sodium metabisulfite in parenteral formulations containing tartrate ions was developed. High-performance ion chromatography (HPIC) method with suppressed conductivity detection was used. A satisfactory separation of SO(3)2- and SO(4)2- was achieved by the proposed HPIC method with 15 mM NaHCO3/0.6 mM Na2CO3 mobile phase and columns with various packing materials: methacrylate polymer -Allsep A-2 Anion (100 x 4.6 mm, 7 microm) and styrene-divinylbenzene copolymer - IonPac AS14A (250 x 4.0 mm, 7 microm). Use of the Allsep A-2 Anion column provides separation of SO(3)2-, SO(4)2- and C4H4O(4)2- present in the investigated products. The calibration plot was linear for 8-267.3 microg/mL sulfite (r = 0.99978, n = 6) and for 3-165.9 microg/mL sulfate (r = 0.9998, n = 6). The limit of detection for SO(3)(2-) and SO(4)2-were 3 microg/mL and 1 microg/mL, respectively.
authors.affiliation: Department of Basic and Applied Pharmacy, National Medicines Institute, 30/34 Chelmska St., 00-725 Warszawa, Poland. marza@il.waw.pl
authors.forename: Marzena
authors.initials: M
authors.lastname: Podolska
authors.forename: Wanda
authors.initials: W
authors.lastname: Białecka
authors.forename: Anna
authors.initials: A
authors.lastname: Kulik
authors.forename: Barbara
authors.initials: B
authors.lastname: Kwiatkowska-Puchniarz
authors.forename: Aleksander
authors.initials: A
authors.lastname: Mazurek
mesh_terms: D000975:Antioxidants / Q000032:analysis*; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002852:Chromatography, Ion Exchange; D004355:Drug Stability; D004553:Electric Conductivity; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D015203:Reproducibility of Results; D013447:Sulfites / Q000032:analysis*
chemical_list: D000975:Antioxidants; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D013447:Sulfites; C005200:sodium metabisulfite