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更新于：2025-07-19
Azelnidipine
阿折地平
更新于：2025-07-19
概要
基本信息
药物类型 小分子化药 |
别名 Azelnidipine (JP17/INN)、CS-905、RS 9054 + [5] |
作用方式 阻滞剂 |
作用机制 L-type calcium channel阻滞剂(L-型电压门控性钙通道家族阻滞剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2003-01-31), |
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C33H34N4O6 |
InChIKeyZKFQEACEUNWPMT-UHFFFAOYSA-N |
CAS号123524-52-7 |
关联
34
项与 阿折地平 相关的临床试验CTRI/2024/08/072999
Comparison of the Efficacy of 24 Hour BP Control of Azelnidipine, Amlodipine and Cilnidipine in Mild to Moderate Essential Hypertension – a Prospective Multi-centric Parallel Arm Real-world Study (AMCILAZ-EH Study) - AMCILAZ-EH Study
CTRI/2024/08/071803
Post-approval, case control analyses to assess clinical safety and effectiveness of Azelnidipine and Cilnidipine as initial -addon therapy in management of T2DM with HTN - HYDIAZ
CTRI/2024/07/071061
Post-approval, observational study to assess clinical safety and effectiveness of Azelnidipine and Telmisartan in management of Diabetic HTN - TELAZ
100 项与 阿折地平 相关的临床结果
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100 项与 阿折地平 相关的转化医学
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100 项与 阿折地平 相关的专利（医药）
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539
项与 阿折地平 相关的文献（医药）2025-02-08JOURNAL OF CHROMATOGRAPHIC SCIENCE
An Analytical Approach by Tri-Combination of Gradient UFLC, Response Surface Methodology and Green Chemistry Principle for Simultaneous Quantification of Azelnidipine and Chlorthalidone in Rabbit Plasma
Article
作者: Ramesh, B ; Sahariah, Bhargab Jyoti ; Majumder, Manish ; Bhagyalakshmi, C ; Dutta, Koushik Nandan ; Longkumer, Piyongsola ; Rekha, T N
Abstract:
In this study, a sustainable and eco-friendly method is developed to quantify azelnidipine and chlorthalidone in rabbit plasma by gradient liquid chromatography based on green chemistry principle and analytical quality by design. The separation was achieved on a Shim pack C18 (25 cm × 5 cm × 4.6 μm) column with L1 packing. The mobile phase compromised of ethanol and 50-Mm ammonium acetate buffer (pH.6) at flow rate of 0.6 mL/min with 25-min runtime. The resolution and asymmetric factor were identified as critical analytical attributes (CAAs). The screening studies employing Control Noise Experimentation revealed that mobile phase pH, flow rate and ethanol concentration at 6 and 15 min significantly affected the CAAs method. The critical method parameters were optimized using Central Composition design. Chromatogram showed peak of the drugs at retention time of 9.03 min for chlorthalidone and 16.83 min for azelnidipine. The greenness score of the analytical method was found to be 1876.43 using analytical method greenness score calculator. The validation of the developed method was done which showed linearity at the range of 16–520 ng/mL, with R2 of 0.9992 and 0.9996 for azelnidipine and chlorthalidone, respectively, furthermore accuracy, precision, recovery and stability studies are carried out.
2024-12-01INDIAN JOURNAL OF HETEROCYCLIC CHEMISTRY
Stability indicating analytical method development and validation for azelnidipine and chlorthalidone by LC-MS method
作者: Nandhu, R. ; Manikandan, M. ; Gandhi, Meenal ; Sanjay, S. ; Tharik, A. Mohamed Sheik
An accurate, precise, and reproducible HPLC-MS-based stability-indicating was developed and validated for the simultaneous quantitative determination of Azelnidipine (AZL) and Chlorthalidone (CTE). HPLC-MS method employs an X Bridge C18 column (5 μm, 4.6 x 250 mm) and a mobile phase, 5mM Potassium dihydrogen phosphate: Acetonitrile (10:90 v/v) ratio with, pH 7.8 adjusted using Triethylamine, for the simultaneous determination of AZL and CTE. The detection was carried out at 261 nm with a flow rate of 1.0 ml/min. The method reveals linearity over the concentration ranges of 0.1-0.6 mcg/ml for AZL and 0.16-0.96 mcg/ml for CTE with correlation coefficients of 0.9901 and 0.9988, respectively. Precision (%RSD) for intraday analysis was found to be 0.98% for AZL and 0.88% for CTE. Accuracy was negotiated at three different concentrations, and the results indicated %Recovery within acceptable limits. Limits of detection and quantification were determined to be 52 ng/ml and 45.6 ng/ml for both compounds, respectively.. KEYWORDS :Azelnidipine, Chlorthalidone, LC-MS, Stability-Indicating method, Method development.
2024-12-01INDIAN JOURNAL OF HETEROCYCLIC CHEMISTRY
Stability Assessment through HPTLC for Concurrent Assessment of Azelnidipine and Telmisartan in Mass and Integrated Tablet Drug Formulation
作者: Jayashree, J. ; Mohan, S. ; Haribhuvanesh, P.
This study aims to estimate the stability assessment through HPTLC for the concurrent assessment of (±)3-(1-diphenylmethylazetidin-3-yl)5-isopropyl-2-amino-1,4-dihydro-6-methyl-4-(3-nitrophenyl)-3,5-pyridine dicarboxylate (Azelnidipine) and 2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl] phenyl]benzoic acid (Telmisartan) in combined tablet formulation, a new HPTLC approach devised and validated that is simple, quick, precise, selective, and accurate stability suggesting. The adsorbent phase used is previously coated with a silica pack on TLC aluminum plates with 60F-254 using Chloroform: Ethyl acetate (5:5 v/v) of a total of 10 ml as the mobile phase. Both Azelnidipine (Rf 0.70) and Telmisartan (Rf 0.17), at 254 nm, densitometric scanning was performed in the reflectance absorptivity mode. In the linearity range of 1-6 μg/ml for Azelnidipine and 5-30 μg/ml for Telmisartan, the calibration graph demonstrated satisfactory linearity with r2 = 0.9967 and 0.9966, respectively. Azelnidipine and Telmisartan percentage assays were discovered to be 98.87 and 100.17. The percent RSD for intraday AZL and TLM experiments was 0.0184 and 0.0068. The percent RSD for AZL and TLM interday trials was discovered as 0.0126 and 0.0068. The LOD for AZL and TLM was discovered as 910 ng/mark and 4570 ng/mark. AZL and TLM were discovered to have LOQs of 2763 ng/mark and 13850 ng/mark, respectively. According to the ICH guidelines, drugs were exposed to acidic, basic, oxidative, photo, and heat-activated degradation. The medication degrades in acidic, basic, oxidative and heat environments but not in light or neutral environments (water). This procedure can be used to efficiently isolate the drug substance from its degradation products and this is used to indicate strength and stability.. KEYWORDS :Azelnidipine, Telmisartan, HPTLC, UV-visible spectroscopy, Validation, Stability studies.
1
项与 阿折地平 相关的新闻（医药）
100 项与 阿折地平 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 |
|---|---|---|---|
| 高血压 | 日本 | 2003-01-31 |
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临床结果
临床结果
适应症
分期
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N/A | 36 | 醖網襯衊鏇鏇構淵積鏇(顧積鹽繭齋鑰壓積簾鹹) = 鏇醖鹹製夢鏇觸壓廠膚 遞醖繭鹹夢窪鬱糧顧鹹 (範遞願選窪範鹽艱齋網 ) | - | 2020-02-01 | |||
醖網襯衊鏇鏇構淵積鏇(顧積鹽繭齋鑰壓積簾鹹) = 糧簾範選觸壓選淵憲醖 遞醖繭鹹夢窪鬱糧顧鹹 (範遞願選窪範鹽艱齋網 ) | |||||||
N/A | - | 顧膚餘鹽遞範鬱醖簾範(鑰觸窪憲顧選淵醖齋網) = 鏇襯艱窪觸醖憲選範襯 醖夢築壓積鏇齋簾簾選 (範齋壓選壓網鏇鹽築鹹 ) 更多 | 积极 | 2012-09-01 | |||
顧膚餘鹽遞範鬱醖簾範(鑰觸窪憲顧選淵醖齋網) = 構淵淵餘鏇鹽壓襯鏇鹽 醖夢築壓積鏇齋簾簾選 (範齋壓選壓網鏇鹽築鹹 ) 更多 | |||||||
N/A | - | 鹽築廠鹹鏇遞糧積積遞(遞淵餘廠製憲壓願鹽網) = 觸獵襯膚築餘淵夢糧觸 壓範淵製淵積範遞鏇選 (鹽築選選憲夢窪範積廠, 5) 更多 | 积极 | 2010-06-01 | |||
鹽築廠鹹鏇遞糧積積遞(遞淵餘廠製憲壓願鹽網) = 糧憲衊獵齋淵築艱鬱夢 壓範淵製淵積範遞鏇選 (鹽築選選憲夢窪範積廠, 4) 更多 |
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