Qualification of TLC-equipment used in analysis of the combined herbal medicines
Keywords:quality control system, analysis, TLC-equipment, Klimased
On the example of Klimased drug with the purpose of choosing the analytical equipment for quality control of combined drugs of the plant origin the study on major functional and performance characteristics (design qualification) of the equipment used according to pharmacopoeial requirements(SPhU and USP) and the target analytical tasks has been conducted. It allows to select equipment for an enterprise. A comparative analysis of functional and technical specifications of the devices to perform analysis of the combined drugs from the medicinal plant raw material by the method of thin-layer chromatography has been conducted. It has been experimentally proven that the configuration of the chromatographic chamber does not affect the result of the analysis, chambers manufactured by Sorbfil are more affordable by economic indicators. When analysing the medicinal plant raw material and drugs from it the TLC and HPTLC plates on all substrates with an UV indicator can be used, it is advisable to make the final choice by economic components or their availability. Characteristics of the devices for applying solutions of chromatograms have revealed that when choosing microsyringes the best indicator is its volume. When comparing devices for detecting or quenching fluorescence manufactured by Sorbfil (Russia) and Spectroline (USA) it has been proven that each of the devices studied can be used to identify chromatographic zones. The manufacturer Spectroline has the quality certificate ISO 9001:2008 and is more affordable, therefore, it is superior to irradiator UVS-254/365 manufactured by Sorbfil. Among the devices for spraying chromatograms the sprayers of GGB (USA) have a comfortable design and a suitable volume, but by cost they are much more expensive than sprayers of Sorbfil (Russia). It is advisable to make the final choice based on the economic component.
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