Korodi T, Bukowski K, Lachmann B
Pharmacy Department, Krankenanstalt Rudolfstiftung, Vienna, Austria.
Pharmazie. 2012 Dec;67(12):980-3.
A fast and reproducible high performance liquid chromatography method has been developed for the determination of diclofenac sodium and its degradation products in commercial and in in-house produced ointments. The method employs a RP-LiChrospher select B (C8) column with a mobile phase containing methanol/water (63:37, v/v) and detection at 220 nm. This rapid and simple HPLC assay was used for QA/QC of large scale in-house produced diclofenac gel. The validation protocol was designed following international guidelines, e. g. ICH Q2(R1). Selectivity tests also included the separation of synthesis related by-products like 1-(2,6-dichlorphenyl)indoline-2-one (impurity A) and indoline-2-one (impurity E), and in addition selectivity with regard to several photodegradation products produced by both UV and simulated sunlight irradiation has been shown.
已开发出一种快速且可重现的高效液相色谱法，用于测定市售和自制软膏中双氯芬酸钠及其降解产物。该方法采用RP-LiChrospher select B（C8）柱，流动相为甲醇/水（63:37，v/v），检测波长为220 nm。这种快速简便的高效液相色谱法用于大规模自制双氯芬酸凝胶的质量保证/质量控制。验证方案是按照国际指南（如ICH Q2(R1)）设计的。选择性测试还包括分离合成相关副产物，如1-(2,6-二氯苯基)吲哚啉-2-酮（杂质A）和吲哚啉-2-酮（杂质E），此外还展示了对紫外线和模拟阳光照射产生的几种光降解产物的选择性。
