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更新于：2026-02-01
Saxagliptin Hydrochloride/Metformin Hydrochloride
盐酸沙格列汀/盐酸二甲双胍
更新于：2026-02-01
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2010-11-05), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C22H38Cl2N8O2 |
InChIKeyGTSUONGZHGBCPP-ZEGDOHPJSA-N |
CAS号1431862-06-4 |
关联
27
项与 盐酸沙格列汀/盐酸二甲双胍 相关的临床试验CTR20252379
评估受试制剂沙格列汀二甲双胍缓释片（I）与参比制剂安立格®（Kombiglyze® XR）在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、双交叉生物等效性试验
CTR20251495
沙格列汀二甲双胍缓释片（Ⅰ）（5mg/1000mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验。
CTR20241754
沙格列汀二甲双胍缓释片（I）在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究
100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的临床结果
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100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的转化医学
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100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的专利（医药）
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10
项与 盐酸沙格列汀/盐酸二甲双胍 相关的文献（医药）2021-05-01MICROCHEMICAL JOURNAL
Green methods for the simultaneous analysis of pharmaceutical mixtures present in disparate concentration ranges: Application to antidiabetic mixtures
作者: Amira F. El-Yazbi
Diabetes-mellitus is one of the most common chronic diseases worldwide.Today, many single-pill combinations exist and are indicated especially for diabetic patients who are unable to achieve sufficient glycemic-control with one active component.However, some of these combinations are formulated in concentration ratios that present a real challenge for their anal. and quality-control assessment.For instant, linagliptin (L) and saxagliptin (S) are two oral dipeptidylpeptidase-4 inhibitors that have recently been formulated with metformin (M) in a ratio of 1:400 with almost no simple anal. methods offered in literature for their anal. in such disparate concentration-ratio.In this study, a simple, fast and green capillary electrophoretic (CE) method was established for the simultaneous determination of L and S with M in pharmaceutical-dosage-forms.The developed method was linear in the range of 2-200μg.mL-1 for L and S and 10-2000μg.mL-1 for M with r > 0.9993 with low LOD and LOQ values that allowed the proposed method to be successfully applied for the sensitive determination of S, L and M in their binary-combinations of S-M and L-M in pharmaceutical-dosage-forms despite the large differences in M and L or S doses.Upon comparison with the few reported-methods, the proposed-method offers the advantages of high separation efficiency and low solvent consumption.In addition to using simple aqueous-buffer that adds to the greenness of the method and decrease the cost of operation.The Eco-scale penalty points approach and the Green Anal. Procedure Index were applied to assess the greenness of the developed method.Results revealed that the proposed method is a greener alternative to the reported ones This allows our proposed-method to be used for the routine high-through-put anal. required in quality-control laboratories as an efficient and simple eco- friendly anal.-tool.
2021-01-01Current Pharmaceutical Analysis
Simultaneous Determination of Alogliptin, Linagliptin, Saxagliptin, and Sitagliptin in Bulk Drug and Formulation by UPLC Q-TOF-MS
作者: Kumar, Robin ; Dahiya, Meenakshi ; Singh, Gyanendra Nath ; Chandra, Amrish ; Rathod, Ramji ; Ali, Faraat
Background::
A simple and sensitive Ultra Performance Liquid Chromatography-Mass Spectrometry method was developed and validated to measure the concentrations of Alogliptin (ALO), Linagliptin (LIN), Saxagliptin (SAX), and Sitagliptin (SIT) using Pioglitazone (PIO) as an internal standard.
Methods::
Chromatographic separation of six gliptins was achieved on a C-18 column (100×2.1 mm, 2.7 μm) using a mobile phase consisting of formic acid in water, 0.1%v/v: acetonitrile in gradient elution. Electrospray ionization (ESI) source was operated in the positive ion mode. Targeted MS/MS mode on a QTOF MS was used to quantify the drug utilizing the transitions of 340.1(m/z), 473.2 (m/z), 316.2 (m/z), 408.1 (m/z), and 357.1 (m/z) for ALO, LIN, SAX, SIT and PIO respectively.
Results::
As per ICH Q2R1 guidelines, a detailed validation of the method was carried out and the standard curves were found to be linear over the concentration ranges of 1516.0-4548.1 ng mL-1, 519.8- 1559.4 ng mL-1, 1531.4-4594.3 ng mL-1and 1519.6-4558.8 ng mL-1for ALO, LIN, SAX and SIT respectively. Precision and accuracy results were within the acceptable limits. The mean recovery was found to be 98.8 _ 0.76 % (GEM), 102.2 _ 1.59 % (LIN), 95.3 _ 2.74 % (SAX) and 99.2 _ 1.75 % (SIT) respectively.
Conclusions::
The optimized validated UPLC QTOF-MS/MS method offered the advantage of shorter analytical times and higher sensitivity and selectivity. The optimized method is suitable for application in quantitative analysis of pharmaceutical dosage forms for QC laboratory.
2019-04-03JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets
作者: Maher, Hadir M. ; Abdelrahman, Afnan E. ; Alzoman, Nourah Z. ; Aljohar, Haya I.
A capillary electrophoretic method coupled to a diode array detector (CE-DAD) was developed and validated for the simultaneous determination of metformin hydrochloride (MET), the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin hydrochloride (SAX), and the sodium glucose co-transporter (SGLT 2) inhibitor dapagliflozin (DAP).The proposed method was used for the determination of these drugs in binary antidiabetic combinations namely, SAX/MET, combination I, DAP/MET, combination II, and SAX/DAP, combination III.CE separation was performed on a fused silica capillary with background electrolyte consisting of 30 mM phosphate buffer (pH 6.0) with a high voltage of 30 kV, a pressure of 20 mbar, and an injection time of 40 s.The compounds were detected at 203 nm for SAX/DAP and 250 nm for MET.The method was linear in the concentration range of 10-200 μ g/mL (SAX), 1.25-50 μ g/mL (DAP), and 7.5-1000 μ g/mL (MET).Full validation of the proposed method was performed as per the ICH guidelines.The obtained errors and deviation values did not exceed 2% assessing good accuracy and precision, resp.The stability-indicating potential of the proposed method was proved under different stress-degradation conditions.The proposed method was successfully applied to the anal. of the three binary combinations in their tablets.
100 项与 盐酸沙格列汀/盐酸二甲双胍 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 糖尿病 | 澳大利亚 | 2013-10-10 | |
| 2型糖尿病 | 美国 | 2010-11-05 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 葡萄糖耐受不良 | 临床3期 | 美国 | 2014-03-01 | |
| 多囊卵巢综合征 | 临床3期 | 美国 | 2014-03-01 |
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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3期 | 38 | (Metformin XR) | 鬱淵廠網憲衊淵顧齋襯 = 憲願遞鹹憲範鑰壓壓鑰 製衊淵積構鬱廠鏇選艱 (淵膚獵淵蓋襯鑰艱網願, 鏇廠遞構糧顧糧憲鹹鏇 ~ 獵廠糧膚簾鬱願簾膚廠) 更多 | - | 2017-06-28 | ||
(Saxagliptin) | 鬱淵廠網憲衊淵顧齋襯 = 網觸鏇糧艱遞網夢艱製 製衊淵積構鬱廠鏇選艱 (淵膚獵淵蓋襯鑰艱網願, 膚鑰顧襯簾選糧繭鏇顧 ~ 鹹鑰構憲襯簾範艱獵襯) 更多 | ||||||
临床1期 | 24 | (Treatment A) | 糧窪製衊夢選襯衊築範(繭淵積製鹽選憲製願築) = 觸膚製製鏇憲積憲構襯 襯顧鑰淵衊選鹹範製衊 (選鹹積觸廠夢鏇顧遞餘, 18.52) 更多 | - | 2012-02-08 | ||
(Treatment B) | 糧窪製衊夢選襯衊築範(繭淵積製鹽選憲製願築) = 選蓋膚膚夢鑰膚襯願製 襯顧鑰淵衊選鹹範製衊 (選鹹積觸廠夢鏇顧遞餘, 19.72) 更多 | ||||||
临床3期 | 166 | Metformin+Saxagliptin (Saxagliptin 2.5 mg + Metformin Immediate Release (IR)) | 廠壓遞衊襯蓋蓋夢餘餘(襯壓膚襯鑰網網構齋簾) = 構鹽顧築醖鬱醖觸蓋鬱 獵夢願蓋艱艱簾壓醖願 (糧壓積範衊繭廠獵遞鹹, 0.11) 更多 | - | 2011-12-16 | ||
Placebo+Metformin (Placebo + Metformin IR) | 廠壓遞衊襯蓋蓋夢餘餘(襯壓膚襯鑰網網構齋簾) = 夢簾製餘簾餘鏇鏇淵鏇 獵夢願蓋艱艱簾壓醖願 (糧壓積範衊繭廠獵遞鹹, 0.09) 更多 | ||||||
临床1期 | 30 | (Treatment A) | 壓襯餘艱醖遞製夢觸淵(鏇蓋築齋糧憲範顧顧鹽) = 構範繭憲構齋齋獵築淵 範鏇鬱觸網範衊積夢簾 (鏇膚選廠鹽憲糧繭淵憲, 18.34) 更多 | - | 2011-05-17 | ||
(Treatment B) | 壓襯餘艱醖遞製夢觸淵(鏇蓋築齋糧憲範顧顧鹽) = 獵膚憲憲窪觸糧構衊廠 範鏇鬱觸網範衊積夢簾 (鏇膚選廠鹽憲糧繭淵憲, 23.14) 更多 | ||||||
临床1期 | 24 | (Coadministration of Saxagliptin and Metformin IR (Fasted)) | 顧簾艱繭醖窪夢網獵餘(窪餘願壓製範鹹壓選選) = 遞簾鏇壓淵選衊選鹹夢 鏇齋範窪齋鹽餘鏇鹽淵 (齋糧蓋齋繭願膚壓蓋衊, 2.572) 更多 | - | 2011-03-25 | ||
(Saxagliptin/Metformin FDC (Fasted)) | 顧簾艱繭醖窪夢網獵餘(窪餘願壓製範鹹壓選選) = 夢窪衊獵遞襯遞鹽鏇積 鏇齋範窪齋鹽餘鏇鹽淵 (齋糧蓋齋繭願膚壓蓋衊, 2.266) 更多 |
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