Studies On Biopharmaceutical Analysis And Preclinical Pharmacokinetics Of A Compound Preparation: Xiaobiling Vaginal Suppository

A high performance liquid chromatographic method followed liquid-liquid extraction was developed and validated for the determination of nonoxynol in biological matrix. The calibration curves were linear in each sample range and both inter-day and intra-day RSD were below 10%. And an ion-pair high performance liquid chromatographic method followed protein precipitation was developed and validated for the determination of povidone-iodione, characterized by iodide in biological matrix. The calibration curves were linear in each sample range and both inter-day and intra-day RSD were below 10%. The method has been successfully used to support the pharmacokinetics study of Xiaobiling vaginal suppository, which consisted of nonoxynol and povidone-iodione in beagle dogs and New Zealand rabbits. The pharmacokinetics of control drug and the compound in animals were studied so as to support the pharmacokinetics study in human.