Development and validation of a new isocratic RP-HPLC method for simultaneous determination of sodium metabisulfite and sodium benzoate in pharmaceutical formulation

• Autorzy: Ivković B. , Brborić J. , Dobričić V. , Čudina O.

Identyfikatory

DOI

10.1556/1326.2017.00404

• Języki publikacji: EN

Abstrakty

EN

A simple and convenient reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous separation, identification, and determination of sodium metabisulfite and sodium benzoate in pharmaceutical formulation has been developed and validated. Chromatographic separation was achieved on RP column Zorbax Extend C-18 (150 × 4.6 mm i.d., 3.5 μm particles), and mixture of 0.1% phosphoric acid and acetonitrile in the ratio 62:38 (v/v) was used as a mobile phase. The flow rate was set at 1.0 mL/min with detection wavelength of 275 nm. The method was successfully validated according to International Conference on Harmonization (ICH) guidelines acceptance criteria. The method is selective, as no interferences were observed at retention times corresponding to these analytes. Results of regression analyses (r) and statistical insignificance of calibration curve intercepts (p) proved linearity of the method in defined concentration ranges for sodium metabisulfite and sodium benzoate (0.05–0.15 mg/mL). Relative standard deviations calculated for both analytes in precision testing were below the limits defined for active pharmaceutical ingredients (analysis repeatability: <2%; intermediate precision: <3%). Recovery values were between 98.16% and 101.94%. According to results of robustness testing, chromatographic parameters are not significantly influenced by small variation of acetonitrile content in mobile phase, column temperature, and flow rate. Finally, the method was applied for quantitative determination of investigated preservatives in real sample analysis.

Słowa kluczowe

EN

RP-HPLC; sodium metabisulfite; sodium benzoate; pharmaceutical formulations

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2019
• Tom: Vol. 31, no. 2
• Strony: 133--137
• Opis fizyczny: Bibliogr. 32 poz., rys.

Twórcy

autor

Ivković B.

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, 11000 Belgrade, Republic of Serbia

autor

Brborić J.

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, 11000 Belgrade, Republic of Serbia

autor

Dobričić V.

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, 11000 Belgrade, Republic of Serbia

autor

Čudina O.

• Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade, 11000 Belgrade, Republic of Serbia

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Uwagi

PL

Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2019).