更新于：2024-06-23
Bisoprolol Fumarate
富马酸比索洛尔
更新于：2024-06-23
概要
基本信息
最高研发阶段批准上市 |
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C40H66N2O12 |
InChIKeyVMDFASMUILANOL-WXXKFALUSA-N |
CAS号104344-23-2 |
关联
40
项与 富马酸比索洛尔 相关的临床试验A prospective, open, multicenter, non-interference real-world study evaluating the long-term safety of levamlodipine besylate tablets combined with bisoprolol fumarate tablets in hypertensive populations
富马酸比索洛尔片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验
富马酸比索洛尔片在健康受试者中的随机、开放、两周期、双交叉空腹及餐后生物等效性试验
100 项与 富马酸比索洛尔 相关的临床结果
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100 项与 富马酸比索洛尔 相关的转化医学
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100 项与 富马酸比索洛尔 相关的专利（医药）
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68
项与 富马酸比索洛尔 相关的文献（医药）2024-01-01Journal of separation science
The improvement of routine drug quality control analysis of some antihypertensive drugs using high‐performance thin‐layer chromatography densitometry method with greenness profile evaluation
Article
作者: Tohamy, Salwa I ; Abdelaleem, Eglal A ; Abdelhamid, Nessreen S ; Lashien, Adel ; Amin, Mahmoud M
The common antihypertensive drugs are B‐blockers and diuretics. For the determination of beta‐blocker medicines (bisoprolol fumarate and carvedilol) and diuretic drug (Furosemide), new and accurate chromatographic method has been developed. The separation was achieved using a developing system that includes chloroform:methanol:ethyl acetate:ammonia (6:2:2:0.2 by volume) as a mobile phase and the bands were detected at 240 nm. The concentration ranges were 5–25, 1–7, and 1–3.5 μg/band for bisoprolol fumarate, carvedilol, and furosemide, respectively. This chromatographic approach is the first methodology for simultaneously determining bisoprolol fumarate, carvedilol, and furosemide in their pure forms and in their pharmaceutical dosage forms. The advantages of using known analytical procedures are their simplicity, speed, cost effectiveness, lack of laboriousness, and ability to save time as the three tablets are determined in one step and can be used for routine analysis of the investigated combinations in quality control laboratories. According to International Conference of Harmonization guidelines, the established procedures have been validated, and the results were statistically compared to those obtained by the reported reversed‐phase–high‐performance liquid chromatography methods using Student's t‐test and F‐test, with no significant difference between them, indicating that the proposed methods can be used for routine drug quality control analysis.
2023-09-01Journal of AOAC International
Chromatographic Techniques for Assessment of Bisoprolol Fumarate and Perindopril Arginine in Solid Formulations under Various Stress Conditions and Application to Six Sigma, Content Uniformity, and Comparative Dissolution Approaches.
Article
作者: Omran, Ahmed A ; Mohamed, Mahmoud A ; Binsaleh, Ammena Y ; Mahmoud, Osama A ; Almalki, Manal A
BACKGROUND:
Antihypertensives bisoprolol fumarate (BIS) and perindopril arginine (PER) were simultaneously determined in their pure, bulk, and combined tablet dosage form.
OBJECTIVE:
This study develops a novel, reproducible, and accurate Reversed phase high-performance liquid chromatography (RP-HPLC) and Reversed phase ultra-performance liquid chromatography (RP-UPLC) with photodiode array detection techniques, which were then applied to in vitro dissolution studies.
METHODS:
The first RP-HPLC method relied on isocratic elution using a mobile phase of methanol-0.05 M phosphate buffer pH 2.6 (1 + 1, by volume), and separation was performed using a Thermo Hypersil C8 column (150 mm × 4.6 mm, 5 μm). Ion-pair UPLC was the second method. An acceptable resolution was achieved using an RP-C18 chromatographic column, Agilent Eclipse (100 × 2.1 mm, 1.7 μm), with a mobile phase containing 0.005 M sodium 1-heptane sulfonate-triethylamine (64 + 1 + 35, by volume), adjusted with phosphoric acid to a pH of 2.0. RP-HPLC used a 1.0 mL/min flow rate, while UPLC used 0.5 mL/min, and the two methods used detection at 210 nm.
RESULTS:
Calibration curves of BIS and PER were linear for RP-HPLC and RP-UPLC methods at 0.5-15 and 0.5-40 μg/mL, respectively. BIS and PER had RP-UPLC LODs of 0.22 and 0.10 μg/mL, respectively, and LOQs of 0.68 and 0.31 μg/mL, respectively. As a result, the approach has been effectively applied to in vitro dissolution testing for drugs in generic and reference products, showing that the two products are comparable. The Six Sigma approach was implemented to compare the recommended and United States Pharmacopeia (USP) procedures, which both exhibited process capability index (Cpk) >1.33. A content uniformity test demonstrated that the drugs in their dosage form met the acceptance limit (85-115%). The degradation products were reliably distinguished from pure drugs for a range of retention times.
CONCLUSION:
In their commercial drug product, the proposed method could be used in QC laboratories for concurrent testing, content uniformity, and in vitro dissolution investigations of BIS and PER. The methods were successfully validated per International Council for Harmonisation (ICH) guidelines.
HIGHLIGHTS:
This study is innovative since it is the first to establish and validate specific and reproducible UPLC and HPLC methods for the concurrent quantitation of the studied drugs in their binary mixture and application to lean Six Sigma, content uniformity, and comparative dissolution approaches.
2023-07-01Journal of separation science
Ultra-high-speed liquid chromatography combined with mass spectrometry detection analytical methods for the determination of nitrosamine drug substance-related impurities.
Article
作者: Marles-Torres, Anna ; Galan-Rodriguez, Cristobal ; Bessa-Jambrina, Sergio ; Lopez-Garcia, Ruben
In the present study, five simple, feasible, and sensitive Ultra-high-speed liquid chromatography combined with mass spectrometry detection methods, using electrospray ionization are proposed. These methods were developed and validated for the determination of four different nitrosamine drug substance-related impurities-N-nitrosoacebutolol, N-nitrosobisoprolol, N-nitrosometoprolol, and N-nitrososotalol-in five beta blockers active pharmaceutical ingredients-acebutolol HCl, bisoprolol fumarate, metoprolol tartrate, metoprolol succinate, and sotalol HCl. The proposed methods were validated as per regulatory guidelines. Acquity HSS T3 (3.0 × 100 mm, 1.8 μm) column and formic acid 0.1% in water combined with methanol or acetonitrile were used for chromatographic separation in all methods. The limit of detection and the limit of quantification were found to be in the range of 0.02-1.2 and 2-20 parts per billion, respectively. The accuracy and precision of the five methods have been demonstrated in the working range of each one, giving values of recovery within the range of 64.1%-113.3%, and the regression coefficients (R) were found to be in the range of 0.9978-0.9999. These methods could be used for controlling nitrosamine drug substance-related impurities content for beta blockers drug substances batches manufactured at Moehs group.
100 项与 富马酸比索洛尔 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 心房颤动 | 日本 | 2013-06-14 | |
| 心动过速 | 日本 | 2013-06-14 | |
| 心脏衰竭 | 日本 | 2011-05-20 | |
| 原发性高血压 | 日本 | 1990-09-28 | |
| 心绞痛 | - | 1986-01-01 | |
| 高血压 | - | 1986-01-01 |
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临床4期 | 43 | 鹽鬱淵簾憲簾繭觸繭觸(憲範廠壓襯構獵壓觸繭) = 壓選窪鑰廠製鏇齋壓構 遞糧鬱淵築膚餘夢齋範 (觸觸壓憲製淵製艱築繭, 選積積夢網鏇蓋齋遞窪 ~ 廠衊願餘鑰選遞築繭願) 更多 | - | 2022-03-10 | |||
鹽鬱淵簾憲簾繭觸繭觸(憲範廠壓襯構獵壓觸繭) = 願鹹艱築築膚壓鬱膚醖 遞糧鬱淵築膚餘夢齋範 (觸觸壓憲製淵製艱築繭, 獵艱願獵淵獵齋窪鏇積 ~ 繭繭遞鑰鹹簾遞齋鬱艱) 更多 |
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