Sharma Nitish, Rao Surendra Singh, Kumar Namala Durga Atchuta, Reddy Pingili Sunil, Reddy Annarapu Malleswara
Analytical Research and Development, IPDO, Dr. Reddy's Laboratories Ltd. Bachupally, Hyderabad-500072, A.P, India.
Sci Pharm. 2011 Apr-Jun;79(2):309-22. doi: 10.3797/scipharm.1101-06. Epub 2011 Feb 12.
A selective, specific and stability-indicating gradient reverse phase high-performance liquid chromatographic (HPLC) method was developed for the determination of Ranitidine in presence of its impurities, forced degradation products and placebo substances such as saccharide and parabens. Ultraviolet detection was performed at 230 nm. Separate portions of the drug product and ingredients were exposed to stress conditions to induce oxidative, acidic, basic, hydrolytic, thermal and photolytic degradation. Ranitidine was found to degrade significantly at acidic, basic and oxidative stress conditions but was stable at heat and humidity. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. The method was validated over this range for (i) system suitability (ii) specificity, (iii) precision, (iv) limit of detection and limit of quantification, (v) linearity, (vi) accuracy, (vii) robustness. The method was found to be precise, accurate, linear and robust. The proposed method was successfully employed for estimation of Ranitidine impurities in pharmaceutical preparations.
建立了一种选择性、特异性且具有稳定性指示功能的梯度反相高效液相色谱（HPLC）法，用于在存在杂质、强制降解产物以及安慰剂物质（如糖类和对羟基苯甲酸酯类）的情况下测定雷尼替丁。在230nm处进行紫外检测。将药品和成分的不同部分置于应激条件下，以诱导氧化、酸性、碱性、水解、热解和光解降解。结果发现雷尼替丁在酸性、碱性和氧化应激条件下会显著降解，但在加热和潮湿条件下稳定。所建立的方法按照国际协调会议（ICH）指南进行了验证。该方法在该范围内针对以下方面进行了验证：（i）系统适用性；（ii）特异性；（iii）精密度；（iv）检测限和定量限；（v）线性；（vi）准确度；（vii）稳健性。结果表明该方法精密、准确、线性良好且稳健。所提出的方法成功用于药物制剂中雷尼替丁杂质的测定。
