Content Determination of Urea in Urea [13C] Capsules by High Performance Cation-exchange Chromatogra-phy

VernacularTitle:高效阳离子交换色谱法测定尿素[13C]胶囊中尿素的含量
Author: Guixia LIU ; Jing YAO ; Limin ZUO ; Panpan LI ; Guangzhi SHAN ; Wei JIANG
Keywords: Urea [13C] capsules; Urea; Content determination; High performance cation-exchange chromatography
From: China Pharmacy 2017;28(9):1236-1238
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To determine the content of urea in Urea [13C] capsules by high performance cation-exchange chroma-tography (HPCEC). METHODS:The determination was performed on Zorbax 300 SCX column with mobile phases consisting of acetonitrile-0.1% phosphoric acid (20:80,V/V) at the flow rate of 1.0 mL/min. The detection wavelength was set at 200 nm and column temperature was 35 ℃. The sample size was 20 μL. RESULTS:The linear range of urea was 0.0039-1.0030 mg/ml(r=0.9997). The limit of quantitation was 3.918 μg/mL and the limit of detection was 0.975 μg/mL. RSDs of precision,stability and repetitive test were all lower than 2.0%. The recovery ranged 99.3%-101.0%(RSD=0.67%,n=9). CONCLUSIONS:The meth-od is simple,rapid,sensitive and suitable for the content determination of urea in Urea [13C] capsules.