Development and Validation of a Method for Trace Level Zinc Quantification in Pharmaceutical Zinc Supplements Using a Carboxyl Functional Group Packed Column and Refractive Index Detector.

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL
Nagavardhana Reddy Vanga, Venkata Ratnam Kesamsetty, Kumaraswamy Ummiti, Venkata Nadh Ratnakaram, Hanimi Reddy Bapatu
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引用次数: 0

Abstract

Background: Zinc helps with cell division, growth, wound healing, and carbohydrate breakdown. Humanbeings have to obtain zinc from food or supplements because our bodies do not produce it naturally. In view of the greater advantages (such as low cost, time of analysis, and stability-indicating) compared to other quantification methods (titration, ion chromatography, Atomic absorption spectroscopy) proposed in the literature, a refractive index detector coupled with HPLC has been used in quantification of zinc.

Objective: The goal of this research is to develop and validate a sensitive, low-cost, high-resolution, and stability- indicating method for detecting and quantifying zinc levels in zinc supplement pharmaceutical products (injectables, tablets, and capsules).

Methods: A novel isocratic reverse-phase HPLC method with a refractive index detector (with sensitivity 64, detector temperature 35°C, and positive polarity) was developed using a carboxyl functional group packed column and 0.8% (v/v) formic acid as the mobile phase to detect and quantify zinc content.

Results: The reported method has a good optimal sensitivity (LOQ: 0.006 mg/mL and LOD: 0.002 mg/mL). The correlation coefficient (r) obtained from the zinc calibration plot was greater than 0.998, indicating that the method was linear and that there was a strong correlation between zinc concentration (0.006 mg/mL to 0.375 mg/mL) and peak response. The accuracy at LOQ level was found to be 95-105% and 97-103% at the remaining levels (50, 100, and 150%).

Conclusion: The proposed method was successfully developed and validated as per International council for harmonisation (ICH) guidelines. Therefore, this method can be used for the quantitative testing of zinc in the QC laboratory.

Highlights: A novel method was developed for zinc levels determination in pharmaceutical products using HPLC with a refractive index detector. The present approach has a quick run time of 10 min and is inexpensive.

利用羧基官能团填料色谱柱和折射率检测器开发并验证药用锌补充剂中痕量锌定量方法
背景:锌有助于细胞分裂、生长、伤口愈合和碳水化合物分解。人类必须从食物或补充剂中获取锌,因为我们的身体不能自然产生锌。与文献中提出的其他定量方法(滴定法、离子色谱法、原子吸收光谱法)相比,折射率检测器结合高效液相色谱法具有更大的优势(如成本低、分析时间短、指示稳定):本研究的目标是开发和验证一种灵敏、低成本、高分辨率和稳定性指示的方法,用于检测和定量补锌药品(注射剂、片剂和胶囊)中的锌含量:方法:采用羧基官能团填料色谱柱,以 0.8% (v/v) 甲酸为流动相,建立了一种新型等度反相高效液相色谱法,该方法采用折光检测器(灵敏度为 64,检测器温度为 35°C,极性为正)检测和定量锌的含量:报告的方法具有良好的最佳灵敏度(LOQ:0.006 mg/mL,LOD:0.002 mg/mL)。锌校准图的相关系数(r)大于 0.998,表明该方法线性良好,锌浓度(0.006 毫克/毫升至 0.375 毫克/毫升)与峰值响应之间有很强的相关性。LOQ水平的准确度为95-105%,其余水平(50%、100%和150%)的准确度为97-103%:根据国际协调理事会(ICH)的指导方针,成功开发并验证了所提出的方法。因此,该方法可用于质控实验室的锌定量检测:利用高效液相色谱法和折射率检测器,开发了一种测定药品中锌含量的新方法。该方法运行时间短,仅需 10 分钟,且成本低廉。
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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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