Dept of Pharmaco-Bromatology, Section Medicinal Products, Scientific Institute of Public Health, J Wytmansstraat 14, 1050 Brussels, Belgium.
J Pharm Biomed Anal. 2011 Apr 5;54(5):995-1000. doi: 10.1016/j.jpba.2010.11.036. Epub 2010 Dec 2.
A fully validated UHPLC method for the identification and quantification of folic acid in pharmaceutical preparations was developed. The starting conditions for the development were calculated starting from the HPLC conditions of a validated method. These start conditions were tested on four different UHPLC columns: Grace Vision HT™ C18-P, C18, C18-HL and C18-B (2 mm × 100 mm, 1.5 μm). After selection of the stationary phase, the method was further optimised by testing two aqueous and two organic phases and by adapting to a gradient method. The obtained method was fully validated based on its measurement uncertainty (accuracy profile) and robustness tests. A UHPLC method was obtained for the identification and quantification of folic acid in pharmaceutical preparations, which will cut analysis times and solvent consumption.
开发了一种完全经过验证的 UHPLC 方法，用于鉴定和定量药物制剂中的叶酸。开发的起始条件是从经过验证的 HPLC 条件计算得出的。这些起始条件在四根不同的 UHPLC 柱上进行了测试：Grace Vision HT™ C18-P、C18、C18-HL 和 C18-B（2mm×100mm，1.5μm）。选择固定相后，通过测试两种水相和两种有机相以及适应梯度方法进一步优化方法。根据测量不确定度（准确度概况）和稳健性测试对获得的方法进行了全面验证。获得了一种用于鉴定和定量药物制剂中叶酸的 UHPLC 方法，这将缩短分析时间并减少溶剂消耗。
