A Validated UV Spectroscopic Method for Simultaneous Determination of Benzil and Benzophenone Impurities in Phenytoin Sodium

Korde, Pooja; Pai, P. N. S.

doi:10.14233/ajchem.2014.15952

Cited by 2 publications

(1 citation statement)

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“…For instance, Walash et al developed a spectrophotometric method to determine benzophenone impurity [10]. Another method using multi-wavelength UV-vis spectrophotometry was also developed for benzil and benzophenone impurities [15]. A polarographic method for benzophenone impurity in phenytoin products was also developed and validated as a very sensitive method for benzophenone co-existing with phenytoin [16].…”

Section: Introductionmentioning

confidence: 99%

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

Sungthong

Rattarom

Sato

et al. 2019

Acta Chromatographica

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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 C 8 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.

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Section: Introductionmentioning

confidence: 99%