更新于：2024-09-27
Amlodipine Besylate
苯磺酸氨氯地平
更新于：2024-09-27
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 英国 (1989-03-01), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C26H31ClN2O8S |
InChIKeyZPBWCRDSRKPIDG-UHFFFAOYSA-N |
CAS号111470-99-6 |
关联
146
项与 苯磺酸氨氯地平 相关的临床试验A Prospective, Multi-center, Randomized Trial to Compare Statin Combined With CCB to MRA Combined With CCB in Primary Aldosteronism Treatment
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BIOS2220在健康受试者中随机、开放、两制剂、单次给药、空腹和餐后状态下的生物等效性研究
100 项与 苯磺酸氨氯地平 相关的临床结果
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100 项与 苯磺酸氨氯地平 相关的转化医学
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100 项与 苯磺酸氨氯地平 相关的专利（医药）
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798
项与 苯磺酸氨氯地平 相关的文献（医药）2024-08-01Heliyon
Evaluation of analytical greenness metric for an eco-friendly method developed through the integration of green chemistry and quality-by-design for the simultaneous determination of Nebivolol hydrochloride, Telmisartan, Valsartan, and Amlodipine besylate
Article
作者: Brahman, Pradeep Kumar ; Veerendra, Y V S ; Mankumare, Sharad D. ; CH, Jayaraju ; C, Vinod Kumar ; Ch, Jayaraju ; Mankumare, Sharad D ; Veerendra, Y.V.S.
In recent years, the field of analytical chemistry has witnessed a notable shift towards the adoption of greener chromatographic methods, aiming to minimize the environmental impact. An effective strategy involves substituting conventional harmful organic solvents with environmentally friendly alternatives, reducing the use of hazardous chemicals that contribute to environmental concerns. However, separating drug substances without the use of buffers and organic solvents presence is a big challenge. To overcome this challenge, a combination of quality-by-design (QbD) and green analytical chemistry (GAC) was employed in this study for method development. A high-performance liquid chromatography (HPLC) method was successfully developed and validated for the simultaneous determination of Nebivolol hydrochloride, Telmisartan, Valsartan, and Amlodipine besylate. The method utilized a mobile phase composed of a mixture of 0.1 % formic acid in water (pH: 2.5) and ethanol. A regular octadecyl silica (ODS) column was employed, and UV detection at 220 nm was utilized. The method exhibited linearity within the concentration range of 25-75 μg/mL for Telmisartan and 150-450 μg/mL for Nebivolol Hydrochloride, Valsartan, and Amlodipine besylate and the correlation coefficient was greater than 0.999 for all the analytes. Limits of detection (LOD) and quantification (LOQ) were determined as 0.01 and 0.04 μg/mL for Telmisartan, 0.06 and 0.20 μg/mL for Nebivolol Hydrochloride, 0.08 and 0.25 μg/mL for Amlodipine besylate, and 0.14 and 0.46 μg/mL for Valsartan, respectively. The developed method underwent thorough validation, encompassing various parameters such as linearity, accuracy, precision, LOD, LOQ, robustness, and ruggedness. The mean recovery values were observed to range between 98.86 % and 99.89 %. The accuracy demonstrated was consistently above 98.98 % for both intra-day and inter-day precisions were with the relative standard deviations less than 2 %. To establish its robustness, a quality-by-design-based experimental design (DoE) approach was implemented. Additionally, the method's environmental friendliness was evaluated using the Analytical Greenness metric (AGREE) an analytical eco scale, both confirming its alignment with sustainable practices and reduced ecological impact. The sustainability of the solvent used in the current study was evaluated by Green Solvents Selecting Tool (GSST) Further, the developed method greenness was evaluated with the green analytical tools such as Analytical method greenness score (AMGS) and using the recently released White Analytical Chemistry (WAC) using RGB assessment tool. By employing this greener approach to chromatography method, this study contributes to the ongoing efforts in analytical chemistry to promote sustainable practices and minimize the environmental footprint of analytical methods.
2024-08-01JOURNAL OF CHROMATOGRAPHY A
Microchip isotachophoresis for green and sustainable pharmaceutical quality control: Method validation and application to complex pharmaceutical formulations
Article
作者: Hradski, Jasna ; Szucs, Roman ; Masár, Marián ; Ďuriš, Marta
Universal microchip isotachophoresis (μITP) methods were developed for the determination of cationic and anionic macrocomponents (active pharmaceutical ingredients and counterions) in cardiovascular drugs marketed in salt form, amlodipine besylate and perindopril erbumine. The developed methods are characterized by low reagent and sample consumption, waste production and energy consumption, require only minimal sample preparation and provide fast analysis. The greenness of the proposed methods was assessed using AGREE. An internal standard addition was used to improve the quantitative parameters of μITP. The proposed methods were validated according to the ICH guideline. Linearity, precision, accuracy and specificity were evaluated for each of the studied analytes and all set validation criteria were met. Good linearity was observed in the presence of matrix and in the absence of matrix, with a correlation coefficient of at least 0.9993. The developed methods allowed precise and accurate determination of the studied analytes, the RSD of the quantitative and qualitative parameters were less than 1.5% and the recoveries ranged from 98 to 102%. The developed μITP methods were successfully applied to the determination of cationic and anionic macrocomponents in six commercially available pharmaceutical formulations.
2024-08-01Journal of pharmaceutical and biomedical analysis
Targeted and untargeted screening for impurities in losartan tablets marketed in Germany by means of liquid chromatography/high resolution mass spectrometry
Article
作者: Kinzig, Martina ; Backer, Laura ; Holzgrabe, Ulrike ; Scherf-Clavel, Oliver ; Sörgel, Fritz
Technical advances in the field of quality analysis allow an increasingly deeper look into the impurity profile of drugs. The ability to detect unexpected impurities in addition to known impurities ensures the supply of high-quality drugs and can prevent recalls due to the detection of harmful unexpected impurities, as has happened recently with the N-nitrosamine and azido impurities in losartan (LOS) drug products. In the present study, the LC-MS/HRMS approach described by Backer et al. was applied to an even more complex system, being the investigation of 35 LOS drug products and combination preparations purchased in 2018 and 2022 in German pharmacies. The film-coated tablets were analysed by means of four LC-MS/HRMS method variants. For the separation a Zorbax RR StableBond C18 column (3.0 ×100 mm, particle size of 3.5 µm, pore size of 80 Å), a gradient elution and for mass spectrometric detection a qTOF mass spectrometer with electrospray ionization in positive and negative mode was used. An information-dependent acquisition method was applied for the acquisition of high-resolution mass spectrometry data. The combination of an untargeted and a targeted screening approach revealed the finding of eight impurities in total. Beside the five LOS related compounds, LOS impurity F, J, K, L, M, and related compound D from amlodipine besilate, LOS azide and an unknown derivative thereof were detected. Identification and structure elucidation, respectively, were successfully performed using in silico fragmentation. Differences in the impurity profiles of drug products from 2018 and 2022 could be observed. This study shows that broad screening approaches like this are applicable to the analysis of drug products and can be an important enhancement of the quality assurance of medicinal products.
100 项与 苯磺酸氨氯地平 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 吞咽障碍 | 加拿大 | 2019-01-11 | |
| 心绞痛 | 英国 | 1990-01-01 | |
| 变异型心绞痛 | 英国 | 1990-01-01 | |
| 稳定型心绞痛 | 英国 | 1990-01-01 | |
| 冠心病 | 英国 | 1990-01-01 | |
| 高血压 | 英国 | 1989-03-01 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 16 | 壓繭廠鹽蓋憲窪獵醖鬱(糧壓夢觸築觸艱簾衊餘) = 膚鹹鏇繭遞壓壓鑰鹽憲 廠網築範憲醖繭壓蓋夢 (築簾願淵醖壓齋選窪鏇, 範齋網積廠鹽鹽積鹹網 ~ 鬱餘鹹願構糧築鹽鏇醖) 更多 | - | 2019-02-06 | |||
临床1期 | 47 | Amlodipine (Amlodipine 10 Milligrams) | 顧蓋糧糧淵範衊獵鏇鹽(鑰獵願鏇醖衊構構淵網) = 憲鹽鹽製鏇餘糧鏇鏇獵 願繭築製壓鹽獵觸鹹鬱 (積餘鬱網願衊壓獵淵鑰, 願壓蓋夢製鏇鏇糧鑰壓 ~ 蓋壓鹽餘鑰衊鑰襯願選) 更多 | - | 2010-07-08 | ||
placebo (Placebo) | 顧蓋糧糧淵範衊獵鏇鹽(鑰獵願鏇醖衊構構淵網) = 夢選觸醖蓋鑰願遞遞淵 願繭築製壓鹽獵觸鹹鬱 (積餘鬱網願衊壓獵淵鑰, 鏇夢鏇壓觸鬱夢選艱齋 ~ 鏇選鑰膚艱襯築願願簾) 更多 | ||||||
临床1期 | - | 28 | (Amlodipine Besylate) | 鑰醖構壓餘構繭範願夢(糧選範衊夢鑰願窪範積) = 鬱膚醖醖憲繭鏇憲鑰淵 醖鹽衊繭鑰鬱憲願鑰選 (繭醖選鹹糧襯廠鹽衊選, 鏇憲艱選襯餘膚積製蓋 ~ 築積襯鏇淵願齋鹽糧廠) | - | 2009-08-18 | |
(Norvasc®) | 鑰醖構壓餘構繭範願夢(糧選範衊夢鑰願窪範積) = 簾衊糧齋窪衊窪淵築築 醖鹽衊繭鑰鬱憲願鑰選 (繭醖選鹹糧襯廠鹽衊選, 選憲觸鬱範網網窪選簾 ~ 餘顧構膚製廠衊鑰壓膚) 更多 | ||||||
临床1期 | - | 28 | 鑰齋構夢鑰鹽選遞夢廠(構衊淵網膚廠窪選簾選) = 鏇憲窪獵鹹鹽願醖膚糧 鑰廠繭鑰網廠網構鬱糧 (製艱餘窪鹽醖築窪網鑰, 襯壓鏇蓋選鹹鏇遞蓋顧 ~ 廠艱構鬱構夢膚觸鹹艱) 更多 | - | 2009-08-18 |
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