Development and standardization of test systems based on filter paper and modified with vanillin reagent

Vadim Prokopets,Oleksandr Zdoryk,Viktoria Georgiyants

doi:10.15587/2519-4852.2017.109254

Abstract

Reagents and analytical tools for rapid analysis should be standardized and lead to the requirements of the State Pharmacopoeia of Ukraine. Newsprint paper is used as the main analytical tool for rapid analysis of substances with primary aromatic amino group, but it can’t be standardized. The development of test systems based on filter paper and modified with pharmacopeia reagents can be the problem solution. Aim. The aim of the work is development and implementation of test-kits based on filter paper for rapid analysis of compounded preparations that contain primary aromatic amino group in conditions of pharmacies. Methods. Methods of physical immobilization; determination of physical stability of test kits; economic and statistical methods (cost calculation); validation of analytical methods; statistical methods of data processing chemical experiment. Results. Filter paper and pharmacopeia solution of vanillin were used to develop test systems; the possibility of using the test system in practice was investigated with the application of rapid analysis of sulfacetamide and sulfathiazole sodium. The possibility of using of the test system for rapid analysis of 5% aqueous solutions of derivatives of sulfanilic acid amides has been proved; the following detection limits and unreliability intervals for the rapid analysis method using test systems were established: 5.0-9.0 mg/ml for sodium sulfacetamide and 5.3-9.6 mg/ml for sodium sulfathiazole. The test system is stable during 5 months of storage. Manufacturing cost of 1 test system is 0.34 and 0.16 UAH for the first and the next batches, respectively. Conclusions. The proposed test system is stable and accessible for usage in pharmacy as an analytical tool for rapid analysis of derivatives of sulfanilic acid amides

Highlights

Despite the widespread use of polymeric materials as matrices for the immobilization of reagents on the test kits, usage of cellulosic and filter paper bases for the manufacturing of test kits is promising in the medical field, in particular for the determination of glucose in the blood [1]
There are modern developments of a test kits that allow the detection of concomitant substances and impurities in complex organic compounds, in particular the detection of Mg2+ in latex of natural rubber [5]
The test kit based on filter paper (FP), modified with a pharmacopoeia vanillin reagent was developed and tried out in practice for identification of active pharmaceutical ingredients (APIs) that contain in its structure primary aromatic amino group (PAAG); 2

Summary

Introduction

Despite the widespread use of polymeric materials as matrices for the immobilization of reagents on the test kits, usage of cellulosic and filter paper bases for the manufacturing of test kits is promising in the medical field, in particular for the determination of glucose in the blood [1]. Test kits can be used in the practice of healthcare facilities and in home conditions [1] This matrix is safe and available for use, so it can be used for test kits manufacturing intended for in vivo testing, including humans [2]. Paper bases are used for creation of chemical test kits, and biochemical and biological test tools, in particular [3], for detection of Escherichia coli in food. It is widely known about test kits usage for pollution monitoring, such as test kits for semiquantitative analysis of arsenic ions in drinking water [4]. The use of testing methods and, in particular, test systems on a paper basis as part of the confirmatory approach of the Quality Control (QC) [7, 8] allows optimizing the cost of reagents and the working time of the pharmacist-analyst [9]

Objectives

Conclusion