Ahmed Sameh, Elshaboury Salwa R, Mohamed Niveen A, Farrag Shereen
Pharmacognosy and Pharmaceutical Chemistry Department, College of Pharmacy Taibah University, Al Madinah AlMunawarah 30001, Saudi Arabia.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt.
J Chromatogr Sci. 2017 Sep 1;55(8):818-831. doi: 10.1093/chromsci/bmx042.
A comparative force degradation high performance thin layer chromatography (HPTLC) method was developed and validated for some H2-receptor antagonists. The studied H2-receptor antagonists were ranitidine (RAN), nizatidine (NIZ) and famotidine (FAM). The degradation behaviors of the studied H2-receptor antagonists were studied under different stress conditions (hydrolytic, thermal and oxidative) conditions as well as storage conditions according to International Conference on Harmonization (ICH) recommendations. A stability-indicating HPTLC method was optimized in order to separate the analyte from the degradation products formed under various stress conditions. Full separation of the drugs from their degradation products was successfully achieved on an HPTLC precoated silica gel plates. Densitometric measurements were carried out using a Camag TLC Scanner III in the absorbance mode at 320 nm for RAN and NIZ, and 280 nm for FAM. The limits of detection and limits of quantitation range were 5.47-9.37 and 16.30-31.26 ng/band, respectively, for all investigated drugs. The validation studies were performed according to ICH requirements. The developed method was simple, rapid and reliable hence it could be applied for routine quality control analysis of the investigated H2-receptor antagonists in dosage forms. The kinetic behavior, degradation rate constants and half-lives of the degradation of the investigated drugs were studied and compared at different stress conditions. The present study provides, for the first time, a new vision to compare the degradation kinetics of H2-receptor antagonists at the same degradation procedures.
开发并验证了一种用于某些H2受体拮抗剂的比较性强制降解高效薄层色谱（HPTLC）方法。所研究的H2受体拮抗剂为雷尼替丁（RAN）、尼扎替丁（NIZ）和法莫替丁（FAM）。根据国际协调会议（ICH）的建议，在不同的应激条件（水解、热和氧化）以及储存条件下研究了所研究的H2受体拮抗剂的降解行为。优化了一种稳定性指示HPTLC方法，以将分析物与在各种应激条件下形成的降解产物分离。在HPTLC预涂硅胶板上成功实现了药物与其降解产物的完全分离。使用Camag TLC Scanner III在吸光度模式下进行密度测定，RAN和NIZ在320 nm处检测，FAM在280 nm处检测。所有研究药物的检测限和定量限范围分别为5.47 - 9.37和16.30 - 31.26 ng/条带。根据ICH要求进行了验证研究。所开发的方法简单、快速且可靠，因此可用于所研究的H2受体拮抗剂剂型的常规质量控制分析。研究并比较了所研究药物在不同应激条件下的动力学行为、降解速率常数和降解半衰期。本研究首次为在相同降解程序下比较H2受体拮抗剂的降解动力学提供了新的视角。
