Mayberry D O, Kowblansky M, Lane P A, Wray P E
R. W. Johnson Pharmaceutical Research Institute, Ortho Pharmaceutical Corporation, Raritan, NJ 08869-0602.
J Pharm Sci. 1990 Aug;79(8):746-9. doi: 10.1002/jps.2600790818.
A stability-indicating assay procedure for the determination of norethindrone on the surface of Red Delicious apple slices was developed. The apple slice is homogenized in pH 10 borate buffer solution and norethindrone is then partitioned into chloroform using a diffusion chamber that has a membrane that is permeable to hydrophobic compounds separating the buffer and chloroform. An aliquot of the chloroform extract is then evaporated to dryness and reconstituted in tetrahydrofuran. The reconstituted sample is then chromatographed on a C18 reversed-phase column using a mobile phase consisting of water:tetrahydrofuran:methanol (63:26:11, v/v/v). Detection is in the UV range at 254 nm. The chromatographic system is specific for norethindrone in the presence of its autoxidation products. Stability data indicate that norethindrone is stable for up to 6 h on the surface of Red Delicious apples.
开发了一种用于测定红富士苹果片表面炔诺酮的稳定性指示分析方法。将苹果片在pH 10的硼酸盐缓冲溶液中匀浆，然后使用扩散室将炔诺酮分配到氯仿中，该扩散室具有一层对疏水性化合物可渗透的膜，用于分离缓冲液和氯仿。然后将一部分氯仿提取物蒸发至干，并在四氢呋喃中复溶。然后将复溶后的样品在C18反相柱上进行色谱分析，流动相由水：四氢呋喃：甲醇（63:26:11，v/v/v）组成。检测在254 nm的紫外范围内进行。该色谱系统在炔诺酮存在其自氧化产物的情况下对炔诺酮具有特异性。稳定性数据表明，炔诺酮在红富士苹果表面上最多可稳定6小时。
