Kelly M A, Altria K D, Grace C, Clark B J
School of Pharmacy, University of Bradford, West Yorkshire, UK.
J Chromatogr A. 1998 Mar 6;798(1-2):297-306. doi: 10.1016/s0021-9673(97)01179-5.
Ranitidine hydrochloride is an H2-antagonist which is widely prescribed for the treatment of peptic ulcers. The drug is marketed in a variety of dosage forms including tablets, syrups and injection solutions. A range of synthetic and degradative impurities of ranitidine are known and currently, these impurities are routinely determined using thin-layer chromatography (TLC). Alternatively a high-performance liquid chromatography (HPLC) method has also been employed in the assay of the pharmaceutical preparation. Unlike TLC, capillary electrophoresis (CE) offers the capability to quantify simultaneously both the active drug content and the levels of the related substances. The advantages of simplicity, selectivity, versatility and ease of use of CE offers a complementary separation technique to the established methods of HPLC and TLC in the determination of ranitidine and its related substances. This work represents a comprehensive evaluation of the performance of a developed CE method in the determination of drug-related impurities in both drug substance and various pharmaceutical formulations. The data obtained clearly shows that the performance of an optimised CE method can be equivalent in terms of sensitivity and precision to that of a HPLC method employed for a similar purpose and offers better selectivity against TLC and HPLC.
盐酸雷尼替丁是一种H2拮抗剂，广泛用于治疗消化性溃疡。该药物有多种剂型上市，包括片剂、糖浆剂和注射剂。雷尼替丁有一系列合成杂质和降解杂质，目前，这些杂质通常采用薄层色谱法（TLC）进行测定。另外，高效液相色谱法（HPLC）也已用于药物制剂的分析。与TLC不同，毛细管电泳（CE）能够同时定量活性药物含量和相关物质的水平。CE的简单性、选择性、通用性和易用性等优点为在测定雷尼替丁及其相关物质时，提供了一种与既定的HPLC和TLC方法互补的分离技术。这项工作全面评估了所开发的CE方法在测定原料药和各种药物制剂中与药物相关杂质方面的性能。所获得的数据清楚地表明，优化后的CE方法在灵敏度和精密度方面可与用于类似目的的HPLC方法相当，并且对TLC和HPLC具有更好的选择性。
