Determination of Related Substances in Pharmaceutical Excipient Benzyl Alcohol by GC / 中国药师

ABSTRACT

To establish a GC method to determine the related substances in pharmaceutical excipient benzyl alcohol. Methods:A GC method was used with an Agilent DB-wax eapillary column(0. 32 mm × 30 m,1. 8 μm)and programming temperature. The initial temperature was 50℃, and then raised to 220℃ with a rate of 5℃·min-1 and maintained for 35min. The detector was FID. The temperature of the injection port was 200℃,and the detector temperature was 310℃. The results were confirmed by GC-MS. Results:Within a certain range,the peak area and concentration of every impurity had a good linear relationship (r≥0. 999 9). The recovery was between 96. 1% and 102. 7%. The quantitative limit was between 1. 37-3. 63 ng. Toluene, benzyl chloride, benzalde-hyde and benzyl ether were found out in the samples. Conclusion:The method is accurate and convenient, and suitable for the quanti-tative determination of related substances in pharmaceutical excipient benzyl alcohol.