Buck R H, Cholewinski M, Maxl F
Sandoz Pharma Ltd., Basle, Switzerland.
J Chromatogr. 1991 Jul 12;548(1-2):335-41. doi: 10.1016/s0021-9673(01)88616-7.
Ornipressin is a peptide drug which is usually assayed by a test on live rats. In order to reduce the animal experiments an alternative method was developed which uses gradient high-performance liquid chromatography (HPLC) on reversed-phase. The HPLC method was validated and shown to be selective and precise. Correlation studies were performed on samples of different dosage strengths and on thermally degraded samples, showing good correlation with the results obtained by the biological assay. The HPLC method was applied on various batches of ornipressin in bulk and in pharmaceutical preparations. HPLC is a rapid and inexpensive method which can replace the animal assay. A new quality control concept is proposed which uses HPLC for the analysis of ornipressin in bulk and in pharmaceutical preparations. With this concept animal testing can be reduced by 90%.
奥曲肽是一种肽类药物，通常通过对活大鼠进行试验来测定。为了减少动物实验，开发了一种替代方法，该方法采用反相梯度高效液相色谱法（HPLC）。HPLC方法经过验证，具有选择性和精确性。对不同剂量强度的样品和热降解样品进行了相关性研究，结果表明与生物测定法得到的结果具有良好的相关性。HPLC方法应用于各种批量的原料药和药物制剂中的奥曲肽分析。HPLC是一种快速且成本低廉的方法，可替代动物试验。提出了一种新的质量控制概念，即使用HPLC分析原料药和药物制剂中的奥曲肽。采用这一概念可将动物试验减少90%。
