Development and validation of a new RP-HPLC-UV method for the simultaneous determination of phenytoin impurities, benzophenone, and benzil

• Autorzy: Sungthong Bunleu , Rattarom Ruchilak , Sato Vilasinee Hirunpanich , Sato Hitoshi

Identyfikatory

DOI

10.1556/1326.2018.00447

• Języki publikacji: EN

Abstrakty

EN

A new reversed-phase high-performance liquid chromatographic method with ultraviolet detection (RP-HPLC-UV) for simultaneous determination of phenytoin impurities, benzophenone and benzil, was developed and validated according to the International Council for Harmonization (ICH) guidelines. Chromatographic separation was performed on a C8 column using acetonitrile–1% acetic acid (60:40, v/v). The correlation coefficients of the calibration lines were greater than 0.999 with 95% confident interval of y-intercept over the origin. The analytical method showed good precision, intra-day precision ≤1.00 and inter-day precision ≤1.53. The standard solution of each compound exhibited good stability 99.18–99.70%, after storage at room temperature for 24 h. The limit of detection (LOD) and limit of quantification (LOQ) were 0.0015 and 0.005 μg/mL, respectively. The resolution of the impurities was 2.935 ± 0.009. The proposed analytical method was successfully applied to determine the amount of benzophenone and benzil in marketed products. The amount of benzophenone was found at 3.09–5.91 × 10−3%, while benzil was not detected in the samples.

Słowa kluczowe

EN

benzil; benzophenone; C8 column; HPLC; phenytoin impurities

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2019
• Tom: Vol. 31, no. 4
• Strony: 241--245
• Opis fizyczny: Bibliogr. 21 poz., rys., tab.

Twórcy

autor

Sungthong Bunleu

• Pharmaceutical Chemistry and Natural Products Research Unit, Faculty of Pharmacy, Mahasarakham University, Kantharawichai District, Maha Sarakham, 44150, Thailand

autor

Rattarom Ruchilak

• Pharmaceutical Chemistry and Natural Products Research Unit, Faculty of Pharmacy, Mahasarakham University, Kantharawichai District, Maha Sarakham, 44150, Thailand

autor

Sato Vilasinee Hirunpanich

• Department of Pharmacology, Faculty of Pharmacy, Mahidol University, Rajathevi, Bangkok, 10400, Thailand

autor

Sato Hitoshi

• School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan

Bibliografia

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Uwagi

PL

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