Verma Rajan K, Garg Sanjay
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector 67, SAS Nagar, Punjab 160 062, India.
J Pharm Biomed Anal. 2002 Oct 15;30(3):583-91. doi: 10.1016/s0731-7085(02)00317-5.
A reversed phase HPLC method using C(18) column was developed for the quantitative determination of isosorbide mononitrate (IMN) in the bulk material and extended release dosage forms. The method was specific to IMN and able to resolve the drug peak from the pharmacopoeial impurities and formulation excipients. The method was accurate, precise, and linear within the desired range. In addition to analysis of assay and dissolution samples, the method was successfully used for analysis of drug-excipient compatibility samples of IMN used for development of extended release formulations in our laboratory and their subsequent stability studies. The method was also used for analysis of IMN in commercially available raw material.
建立了一种使用C(18) 柱的反相高效液相色谱法，用于定量测定原料药和缓释剂型中的单硝酸异山梨酯（IMN）。该方法对IMN具有特异性，能够将药物峰与药典规定的杂质及制剂辅料峰分离。该方法在所需范围内准确、精密且呈线性。除了用于含量测定和溶出度样品的分析外，该方法还成功用于分析我们实验室中用于缓释制剂研发的IMN药物-辅料相容性样品及其后续稳定性研究。该方法还用于分析市售原料药中的IMN。
