采用硅胶 60 RP18WF254 的反相高效薄层色谱-密度测定法对烟酰胺在选定药物制剂中的同时测定的验证。
Validation of an RPHPTLC-Densitometric Method Using Silica Gel 60 RP18WF254 for Simultaneous Determination of Nicotinamide in Selected Pharmaceutical Formulations.
机构信息
Institute of Analytical Chemistry, Department of General and Analytical Chemistry, School of Pharmacy and the Division of Laboratory Medicine, Medical University of Silesia in Katowice, 4 Jagiellońska Street, 41-200 Sosnowiec, Poland.
出版信息
J Anal Methods Chem. 2015;2015:631025. doi: 10.1155/2015/631025. Epub 2015 Mar 5.
This research study describes the applicability of silica gel 60 RPW18F254 plates for the development and validation of new, simple, economic, accurate, and precise RPHPTLC-densitometric method suitable for the quantification of nicotinamide (as Vitamin PP) in three marketed preparations. The mobile phase used was methanol-water in volume composition 3 : 7. Detection wavelength was 200 nm. The proposed method was validated according to ICH guidelines and also based on Ferenczi-Fodor and Konieczka reports. Results were found to be linear over a range of 1.00 to 2.00 μg/spot. Limit of detection (LOD) and limit of quantification (LOQ) were 0.15 μg/spot and 0.45 μg/spot, respectively. The percent content of nicotinamide in the investigated preparations was found to be 99.2% (Product 1), 99.3% (Product 2), and 99.4% (Product 3). Developed method is accurate and precise (CV < 3%) and may be successfully applied for the quality control of pharmaceutical formulations containing nicotinamide in the presence of its derivatives, such as N,N-diethylnicotinamide, N-methylnicotinamide, and nicotinic acid.
本研究描述了硅胶 60 RPW18F254 板在开发和验证新的、简单、经济、准确和精密的 RPHPTLC-密度测定法中的适用性，该方法适用于三种市售制剂中烟酰胺（作为维生素 PP）的定量。所用的流动相为甲醇-水，体积比为 3:7。检测波长为 200nm。该方法是根据 ICH 指南进行验证的，同时也参考了 Ferenczi-Fodor 和 Konieczka 的报告。结果表明，在 1.00 至 2.00μg/斑点范围内呈线性。检测限（LOD）和定量限（LOQ）分别为 0.15μg/斑点和 0.45μg/斑点。在所研究的制剂中，烟酰胺的含量分别为 99.2%（产品 1）、99.3%（产品 2）和 99.4%（产品 3）。所开发的方法准确且精密（CV<3%），可成功应用于含有烟酰胺及其衍生物（如 N,N-二乙基烟酰胺、N-甲基烟酰胺和烟酸）的药物制剂的质量控制。
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