Dunn D L, Scott B S, Dorsey E D
J Pharm Sci. 1981 Apr;70(4):446-9. doi: 10.1002/jps.2600700427.
A normal-phase high-performance liquid chromatographic separation for pilocarpine and isopilocarpine was developed which is suitable for the routine analysis of ophthalmic preparations. The method utilizes a column packed with 5-micron silica with a mobile phase of hexane-2% ammonium hydroxide in 2-propanol (70:30). Peak detection is by UV at 220 nm. It is suggested that a partition separation mechanism is involved rather than adsorption. A separation factor (alpha) of 1.17 was obtained with a relative separation (Rs) of 2.13. Column lifetimes were typically 6-8 months with daily use. Several standard pilocarpine-isopilocarpine mixtures and five commercially available ophthalmic solutions from different manufacturers were analyzed. The method was specific for pilocarpine and isopilocarpine in the presence of each other and pilocarpine acid and is a significant improvement over the nonspecific colorimetric methods of analysis.
开发了一种用于毛果芸香碱和异毛果芸香碱的正相高效液相色谱分离方法，适用于眼科制剂的常规分析。该方法使用填充有5微米硅胶的色谱柱，流动相为己烷-2%氢氧化铵的异丙醇溶液（70:30）。通过220nm处的紫外检测进行峰检测。推测其涉及的是分配分离机制而非吸附。分离因子（α）为1.17，相对分离度（Rs）为2.13。色谱柱在每日使用的情况下，使用寿命通常为6至8个月。分析了几种标准的毛果芸香碱-异毛果芸香碱混合物以及来自不同制造商的五种市售眼科溶液。该方法在毛果芸香碱和异毛果芸香碱相互存在以及毛果芸香酸存在的情况下具有特异性，是对非特异性比色分析方法的重大改进。
