VALIDATION OF GAS CHROMATOGRAPHIC AND UV SPECTROMETRIC METHODS OF QUANTITATIVE DETERMINATION OF BUPRENORPHINE ACCORDING TO REQUIREMENTS OF ISO/IEC 17025:2005 STANDARD
The article is considered to the validation of gas-chromatographic and UV spectrometric methods for the quantitative determination of buprenorphine, which is a partial agonist of opioid receptors and having analgesic properties, according to requirements of ISO/IEC 17025:2005. Authors highlight the fact that during the quantitative calculations of the detected narcotic, psychotropic substances, precursors, drugs, virulent and drastic toxic substances in investigated objects submitted for examination, in order to obtain more accurate and reliable data, there is a need for their reliable quantitative determination in accordance with the requirements of ISO/IEC 17025:2005.
Results of quantitative calculation and constructing of calibration curves of narcotic containing buprenorphine are presented as an example. The validation of gas chromatography and UV spectrometry methods was carried according to requirements of the international standard ISO/IEC 17025:2005. Validation of developed methods is executed in according to following parameters: peculiarity (specificity), linearity, accuracy, stability and reproducibility. This article presents calibration dependencies, their linearity is represented, which makes possible to calculate the coefficient k, used in future in calculating the value of uncertainty measurements.
Obtained results of the research and calculations on made allowed to perform quantitative calculations (determinations) of relevant components in the submitted samples for examination on the basis of the methodology developed in the Department of Physical, Technical and Chemical Research of the National Bureau of Expertise of the Republic of Armenia using the obtained values of measurement uncertainty according to requirements of the international standard ISO/IEC 17025:2005. Their practical implementation ensures reliable performance of quantitative determination of buprenorphine are demonstrated. Thus, based on experimental results and validation procedures, forensic expert practice department introduced two methods of analysis: gas-chromatographic and UV Spectrophotometric, providing reliable execution of quantitative determination of buprenorphine according to requirements of the international standard ISO/IEC 17025:2005.
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