Abstract
Aim . The increase in the pharmaceutical market of Ukraine of the range of medicines leads to stricter requirements for their quality. According to the requirements of international standards ISO, ICH, GMP, current legislation of Ukraine and the State Pharmacopoeia of Ukraine, generic drugs must be equivalent, and the analytical methods used for quality control, validated or verified. One of the available methods of analysis used both in pharmacy conditions and in quality control laboratories at enterprises and in independent control and analytical laboratories is absorption spectrophotometry in the ultraviolet and visible areas. Materials and methods. The method of absorption spectrophotometry in the ultraviolet and visible areas is used to quantify the active pharmaceutical ingredients in finished tablet dosage forms when the quantitative determination performed and when conducting pharmaco-technological tests, such as Dissolution and Uniformity of dosage units. Results. To use the method of absorption spectrophotometry for the quantitative evaluation of active pharmaceutical ingredients in finished drugs, it is necessary to verify the proposed methods and examine such validation characteristics as specificity, linearity, accuracy and precision of the proposed methods. At the same time, the uncertainty of the results of the analysis D As ,, expressed as a one-sided confidence interval for the probability of 95 %, and which consists of the uncertainty of sample preparation (D Sp ) and the uncertainty of the final analytical operation (D FAO ), must not exceed the maximum permissible total uncertainty of the analysis (maxD As ). Conclusions. The approaches of the State Pharmacopoeia of Ukraine to the methods for determining the quantitative content of active ingredients in tablets during the tests Quantitative determination, Dissolution, Uniformity of dosage units were studied. The procedure has been proposed for verifying methods for quantitative determination of manufactured drugs using absorption spectrophotometry according to the requirements of the 2nd edition of the State Pharmacopoeia of Ukraine
Highlights
The pharmaceutical industry of Ukraine occupies one of the leading places in the world and is constantly evolving
With the release in 2015 of the 2nd edition of the State Pharmacopoeia, the number of monographs on finished medicines significantly increased, attention is paid to monographs on medicinal plant raw materials, veterinary and homeopathic preparations, serums, vaccines, extemporal formulations, etc
The step in performing the verification procedure after selecting the method of analysis is to calculate the complete uncertainty of the analysis results ( As), expressed as a one-way confidence interval for a probability of 95 %, based on the tolerances of the active ingredient content in the finished drugs in accordance with the requirements of the State Pharmacopoeia of Ukraine [6, 7], which is compared with the maximum permissible uncertainty of the analysis
Summary
The pharmaceutical industry of Ukraine occupies one of the leading places in the world and is constantly evolving. Employees of the State Pharmacopoeia of Ukraine, based on the requirements of the general article "Tablets" and section 2.2.N.2 "Validation of analytical methods and tests", for the production of monographs on finished medicines, the Standard working methodology (SWM) was proposed "The procedure for verification of analytical methods in research laboratories" [7].
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