The aim of the work was to develop and validate a spectrophotometric method for determining metoprolol tartrate in tablets based on the reaction with bromocresol green (BCG). Material and methods. Analytical equipment: two-beam UV-visible spectrophotometer Shimadzu model -UV 1800 (Japan), software UV-Probe 2.62, laboratory electronic balance RAD WAG AS 200/C, pH-meter И-160МИ. The following APIs, dosage forms, reagents and solvents were used in the work: pharmacopoeial standard sample (CRS) of metoprolol tartrate (Sigma-Aldrich, (≥ 98 %, HPLC)), BCG (Sigma-Aldrich, (≥ 98 %, HPLC)), "Metoprolol" tablets 50 mg (Kyivmedpreparat, series 0035415), "Metoprolol" 100 mg (Farmak, series 30421), methanol (Honeywell, (≥ 99.9 %, GC)), ethanol (Honeywell, (≥ 99.9 %, GC)), chloroform (Honeywell, (≥ 99.9 %, GC)), acetonitrile (Honeywell, (≥ 99.9 %, GC)), and ethyl acetate (Honeywell, (≥ 99.7 %, GC)). Results and discussion. A spectrophotometric method was developed for determining metoprolol tartrate by reaction with BCG in a methanol solution using the absorption maximum at a wavelength of 624 nm. Stoichiometric ratios of reactive components were established, which were 1:1. The developed method for the quantitative determination of metoprolol tartrate was validated following the requirements of the SPhU. The analytical method was linear in the concentration range of 5.47-38.30 μg/mL. The limit of detection and quantification were 0.41 μg/mL and 1.24 μg/mL, respectively. According to the «greenness» pictogram of the analytical method using the AGREE method, the score was 0.79, which indicates that the proposed spectrophotometric method for the determination of metoprolol was developed in compliance with the principles of «green» chemistry.Conclusions. A spectrophotometric method for determining metoprolol tartrate in tablets based on the reaction with BCG in compliance with the principles of «green» chemistry has been developed and validated. Furthermore, the developed method for the quantitative determination of metoprolol tartrate was validated following the requirements of the SPhU. In summary, the developed method has a low negative impact on the environment and can be applied for routine pharmaceutical analysis
Аналітичний огляд побічних ефектів та гострих отруєнь прохлороперазином Актуальність. Наведені дані аналітичного огляду токсикологічних наслідків застосування прохлороперазину. Прохлороперазин є досить часто вживаним лікарським препаратом з нейролептичною та антиеметичною активністю, який виробляється як генеричний засіб у багатьох країнах світу у вигляді таблеток, супозиторіїв та ін'єкційних форм. Мета роботи. Проведення аналітичного огляду побічних дій та гострих отруєнь прохлороперазином при контрольованому та неконтрольованому застосуванні. Результати та їх обговорення. Відповідно до даних інформаційних джерел у період з 2010 по 2016 рр. у світі зареєстровано 258 випадків гострого отруєння прохлороперазином. Серед головних причин отруєнь визначені побічні дії препарату під час лікування у терапевтичних дозах. Прохлороперазин несумісний з препаратами, що пригнічують ЦНС, підвищує ризик неонатальних ускладнень при вживанні вагітними. До 10 % від загальної кількості гострих отруєнь прохлороперазином-це летальні випадки через передозування з суїцидальною метою. Визначені лікарські препарати, що застосовувались одночасно з прохлороперазином при суїцидах: клоназепам, лоразепам, апразолам, ібупрофен, напроксен, діазепам, сероквель, депакот тощо. Висновки. Показано, що за умов наявності в установах проведення судово-медичної експертизи методів хіміко токсикологічного аналізу на прохлороперазин кількість зареєстрованих випадків отруєнь препаратом, зокрема в Україні, може бути значно більшою.
The aim of the work was to develop a simple, economical and eco-friendly spectrophotometric method for determining metoprolol tartrate in tablets based on the reaction with bromophenol blue (BPB). Material and methods: A double–beam Shimadzu UV-Visible spectrophotometer, with a spectral bandwidth of 1 nm wavelength accuracy ±0.5 nm, Model –UV 1800 (Japan), Software UV-Probe 2.62, and a pair of 1 cm matched quartz cells, was used to measure the absorbance of the resulting solution. All the chemicals were used in analytical reagent grade. Pharmacopeial standard samples of metoprolol tartrate and bromophenol blue (BPB) were provided by Sigma-Aldrich (≥ 98%, HPLC). The used dosage forms of metoprolol tartrate are tablets of Metoprolol 50 mg and 100 mg. Results and discussion: The method of spectrophotometric determination of the quantitative content of metoprolol tartrate based on its reaction with BPB in a methanol solution has been developed. The stoichiometric ratios of the reactive components as 1:1 were obtained by the methods of continuous changes and the saturation method. The developed method of quantitative determination of metoprolol tartrate was validated. The linearity regression equation was y = 0.0373x + 0.0038, and the obtained correlation coefficient was R2=0.9984. A linear relationship was found between absorbance at λmax and concentration of metoprolol tartrate in the range of 9.56-15.02 µg/mL. The LOD and LOQ values were calculated to be 0.81 µg/mL and 2.67 µg/mL. Conclusions. A simple, economical and eco-friendly spectrophotometric method has been developed for the quantitative determination of metoprolol tartrate in tablets based on the reaction with BPB. The developed method of quantitative determination of metoprolol tartrate was validated in accordance with the requirements of SPhU. We suggest our work with offered detailed and successful solutions for the mentioned aim with less sophisticated equipment for QC lab for routine manufacturing control
The aim of the work was to develop a spectrophotometric method for the determination of rosuvastatin in tablets based on the reaction with BPB in compliance with the principles of «green» chemistry. Material and methods. Analytical equipment: two-beam UV-visible spectrophotometer Shimadzu model -UV 1800 (Japan), software UV-Probe 2.62, electronic laboratory balance RAD WAG AS 200/C. The following APIs, dosage forms, reagents and solvents were used in work: pharmacopoeial standard sample (CRS) of rosuvastatin calcium (Sigma-Aldrich, (≥ 98 %, HPLC)), BCG (Sigma-Aldrich, (≥ 98 %, HPLC)), "Rosuvastatin" tablets 10 mg, 15 mg, 20 mg, methanol (Honeywell, (≥ 99.9 %, GC)), ethanol (Honeywell, (≥ 99.9 %, GC)), chloroform (Honeywell, (≥ 99.9 %, GC)), acetonitrile (Honeywell, (≥ 99.9 %, GC)), and ethyl acetate (Honeywell, (≥ 99.7 %, GC)). Results and discussion. A spectrophotometric method for determining rosuvastatin by reaction with BPB in an acetonitrile solution using the absorption maximum at a wavelength of 595 nm has been developed. Stoichiometric ratios of reactive components were established, which were 1:1. The developed method for the quantitative determination of rosuvastatin was validated following the requirements of the SPhU. The analytical method was linear in the 7.99-23.97 μmol/L concentration range. The LOD and LOQ values were calculated to be 0.77 µmol/L and 2.36 µmol/L. According to the «greenness» pictogram of the analytical method using the AGREE method, the score was 0.77, indicating that the proposed spectrophotometric method for determining rosuvastatin was developed in compliance with the principles of «green» chemistry. Conclusions. An eco-friendly spectrophotometric method has been developed to quantitatively determine rosuvastatin in tablets based on the reaction with BPB. The appropriate sulfophthalein dye (BPB) and its concentration (4.00 x 10-4), the optimal eco-friendly solvent (acetonitrile), and the appropriate wavelength (595 nm) were chosen, and the sensitivity of the reaction was calculated. The analytical method was validated, and its possibility for use in the pharmaceutical analysis was shown
The aim of the work was to develop a simple, economic, fast, reliable, and eco-friendly spectrophotometric method for the determination of atorvastatin in tablets based on the reaction with bromothymol blue (BTB). Material and methods. A double–beam Shimadzu UV-Visible spectrophotometer, with spectral bandwidth of 1 nm wavelength accuracy ±0.5 nm, Model –UV 1800 (Japan), Software UV-Probe 2.62 was used to measure absorbance of the resulting solution. Pharmacopeial standard sample of atorvastatin calcium and BTB were provided by Sigma-Aldrich (≥98 %, HPLC). The used dosage forms of atorvastatin: tablets Atorvastatin 10 mg and 20 mg. Results and discussion. The method of spectrophotometric determination of the quantitative content of atorvastatin calcium based on its reaction with BTB in ethyl acetate medium has been developed. The stoichiometric ratios of the reactive components as 1:1 were obtained by the methods of continuous changes and the saturation method. Linearity regression equation was y=0.0017x+0.0496 and the obtained correlation coefficient was R2=0.9993. The linear relationship was found between absorbance at λmax and concentration of medicine in the range 15.48–154.80 µg/mL. The LOD and LOQ values were calculated to be 4.85 µg/mL and 14.71 µg/mL respectively. Spectrophotometric method for the determination of atorvastatin in tablets using BTB was developed in accordance with GAC principles. Conclusions. A simple, economic, fast, reliable and eco-friendly spectrophotometric method was developed for the determination of atorvastatin calcium in tablets based on the reaction with BTB and validated according to the standardized validation procedure by the standard method. It was proved that according to such validation characteristics as linearity, precision, accuracy, and robustness the proposed method met the requirements of SPhU
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