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1 Acta Chromatographica

1 2019

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

Sungthong Bunleu, Rattarom Ruchilak, Sato Vilasinee Hirunpanich, Sato Hitoshi

Acta Chromatographica

2019

Vol. 31, no. 4

241--245

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.