Lookabaugh M, Biswas M, Krull I S
US Food and Drug Administration, Winchester Engineering and Analytical Center, MA 01890.
J Chromatogr. 1991 Jul 19;549(1-2):357-66. doi: 10.1016/s0021-9673(00)91446-8.
High-performance capillary electrophoresis (HPCE) was evaluated as a potential technique for the regulatory analysis of commercial dosage forms of insulin. A comparison was made to a liquid chromatographic analysis presently being proposed as an official monograph in the United States Pharmacopeia. The salient points of this comparison were accuracy, precision and ease of use. Both authentic (i.e. single blind, spiked) samples and commercial pharmaceutical formulations (injections) were examined. Chromatographic analyses of both commercial formulations and authentic samples were characterized by good precision, with accuracy being supported by results from authentic (spiked) samples. Conventional HPCE (by which is meant a non-micellar electrolyte used with an uncoated, unmodified fused-silica capillary) achieved reasonable accuracy, but less than impressive precision, when applied to authentic samples. When used for commercial formulations, this type of HPCE did not produce a level of accuracy suitable for regulatory purposes, even with the use of an internal standard.
高效毛细管电泳（HPCE）被评估为一种用于胰岛素商业剂型监管分析的潜在技术。与目前美国药典中作为官方专论提出的液相色谱分析进行了比较。该比较的要点是准确性、精密度和易用性。对真实（即单盲、加标）样品和商业药物制剂（注射剂）都进行了检测。商业制剂和真实样品的色谱分析均具有良好的精密度，真实（加标）样品的结果支持了准确性。传统的HPCE（即使用未涂覆、未改性的熔融石英毛细管和非胶束电解质）应用于真实样品时，能达到合理的准确性，但精密度不太理想。当用于商业制剂时，即使使用内标，这种类型的HPCE也无法产生适合监管目的的准确度水平。
