Shantha Kumar T R, Chawla Sonia, Nachaegari Satish K, Singh Sunil Kumar, Srinivas Nuggehally R
Formulation Research Department, Discovery Research, Miyapur, Dr. Reddy's Laboratories Limited, Hyderabad, India.
J Pharm Biomed Anal. 2005 Jun 1;38(1):173-9. doi: 10.1016/j.jpba.2004.11.063. Epub 2005 Jan 21.
A simple, precise and accurate isocratic reverse-phase liquid chromatography method with programmed wavelength detection has been validated to quantify DRF-4367 and Phenol red, simultaneously for application in rat in situ single pass intestinal perfusion study to assess intestinal permeability of DRF-4367, a novel cox-2 inhibitor. The method was validated on RP C-18 analytical column. Mobile phase consisted of sodium dihydrogen orthophosphate (pH 3.2, 0.01 M)-acetonitrile-methanol (30:50:20, v/v/v). The developed method has a short run time of 12 min with a flow rate of 1.0 ml/min. The injector volume was set to 20 microl and acquisition was carried out using a PDA detector while processing was done by timed wavelength extraction. The percentage R.S.D. and recovery in all studies indicated that the method was suitable for the intended purpose. The validated method was found to be linear and precise in the working range. Suitability of storage at cold temperature was ensured along with complete sample recovery.
一种简单、精确且准确的等度反相液相色谱法，采用程序波长检测，已得到验证，可同时定量测定DRF - 4367和酚红，用于大鼠原位单通道肠道灌注研究，以评估新型环氧化酶 - 2抑制剂DRF - 4367的肠道通透性。该方法在反相C - 18分析柱上进行了验证。流动相由磷酸二氢钠（pH 3.2，0.01 M）-乙腈-甲醇（30:50:20，v/v/v）组成。所开发的方法运行时间短，仅12分钟，流速为1.0 ml/min。进样体积设定为20微升，使用PDA检测器进行采集，同时通过定时波长提取进行处理。所有研究中的相对标准偏差百分比和回收率表明该方法适用于预期目的。经验证的方法在工作范围内呈线性且精确。确保了在低温下储存的适用性以及样品的完全回收。
