Abstract
Introduction. Tadalafil is a drug used to treat erectile dysfunction. For the quantitative determination of tadalafil in human plasma are used methods of high performance liquid chromatography with ultraviolet and tandem mass spectrometric detection, during the analytical part of pharmacokinetic studies. In the majority of the considered methods the method of liquid-liquid extraction and the method of solid-phase extraction are used, these methods are difficult and expensive. Therefore, the method of protein precipitation was considered as sample preparation. This method is simple and there is important to analysis a lot of clinical samples in bioequivalence studies.Aim. The aim of this study is to develop method for the quantitative determination of tadalafil in human plasma by HPLC-MS for the analytical part of pharmacokinetic studies.Materials and methods. Quantitative determination of tadalafil in plasma by HPLC-MS. A sample was prepared using acetonitrile protein precipitation.Results and discussion. This method was validated by next validation parameters: selectivity, matrix effect, calibration curve, accuracy, precision, lower limit of quantification, carry-over and stability.Conclusion. The method of the quantitative determination of tadalafil in human plasma was developed and validated by HPLC-MS. The analytical range of the was 5,00–1000,00 ng/ml tadalafil in plasma. Method could be applied to determination of tadalafil in plasma for PK and BE studies.
Highlights
Tadalafil is a drug used to treat erectile dysfunction
The method of protein precipitation was considered as sample preparation
This method is simple and there is important to analysis a lot of clinical samples in bioequivalence studies
Summary
Разработка и валидация методики количественного определения тадалафила в плазме крови человека. Для количественного определения тадалафила в плазме крови человека при проведении аналитической части фармакокинетических исследований применяются методы высокоэффективной жидкостной хроматографии с ультрафиолетовым и тандемным масс-спектрометрическим детектированием. Целью исследования является разработка методики количественного определения тадалафила в плазме крови человека методом ВЭЖХ с одноквадрупольным масс-спектрометрическим детектированием для проведения аналитической части фармакокинетических исследований. Количественное определение тадалафила в плазме крови проводили методом высокоэффективной жидкостной хроматографии с одноквадрупольным масс-спектрометрическим детектированием. Разработана и валидирована методика количественного определения тадалафила в плазме крови человека методом ВЭЖХ-МС. Подтвержденный аналитический диапазон методики составил 5,00–1000,00 нг/мл тадалафила в плазме крови. Полученный аналитический диапазон позволяет применять разработанную методику для проведения аналитической части исследований фармакокинетики и биоэквивалентности воспроизводимых лекарственных средств, содержащих тадалафил. В. Разработка и валидация методики количественного определения тадалафила в плазме крови человека.
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