阿折地平(Azelnidipine) - 药物靶点：L-type calcium channel_在研适应症：高血压_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Azelnidipine (JP17/INN)

+ [5]

靶点

L-type calcium channel

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

心血管疾病

在研适应症

高血压

非在研适应症-

原研机构

Daiichi Sankyo Co., Ltd.

在研机构

Daiichi Sankyo Co., Ltd.

连云港润众制药有限公司

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),

高血压

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

/ RecruitingN/AIIT

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

开始日期2024-09-04

申办/合作机构-

CTRI/2024/08/071803

/ Not yet recruitingN/AIIT

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

开始日期2024-08-13

申办/合作机构-

CTRI/2024/07/071061

/ Not yet recruitingN/A

Post-approval, observational study to assess clinical safety and effectiveness of Azelnidipine and Telmisartan in management of Diabetic HTN - TELAZ

开始日期2024-08-02

申办/合作机构

Torrent Pharmaceuticals Ltd.

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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540

项与阿折地平相关的文献（医药）

2025-02-08·Journal 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: Longkumer, Piyongsola ; Ramesh, B ; Dutta, Koushik Nandan ; Bhagyalakshmi, C ; Rekha, T N ; Majumder, Manish ; Sahariah, Bhargab Jyoti

AbstractIn 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.

2024-12-01·INDIAN JOURNAL OF HETEROCYCLIC CHEMISTRY

Stability indicating analytical method development and validation for azelnidipine and chlorthalidone by LC-MS method

作者: Nandhu, R. ; Gandhi, Meenal ; Tharik, A. Mohamed Sheik ; Manikandan, M. ; Sanjay, S.

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.

2024-12-01·INDIAN JOURNAL OF HETEROCYCLIC CHEMISTRY

Stability Assessment through HPTLC for Concurrent Assessment of Azelnidipine and Telmisartan in Mass and Integrated Tablet Drug Formulation

作者: Haribhuvanesh, P. ; Jayashree, J. ; Mohan, S.

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.

100 项与阿折地平相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01145	阿折地平	C08CA	DB09230

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高血压	日本	Daiichi Sankyo Co., Ltd.	2003-01-31

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


GUARD study (ESH2012)	N/A	糖尿病 \| 高血压	-	Olmesartan + Azelnidipine	(製鹽選積築繭範顧繭蓋) = 網鹹築憲窪鬱醖蓋憲蓋糧築築範簾壓窪簾膚遞 (淵簾簾觸夢廠膚顧構艱 )	积极	2012-09-01
				Olmesartan + Trichlormethiazide	(製鹽選積築繭範顧繭蓋) = 網窪顧艱蓋蓋衊窪襯選糧築築範簾壓窪簾膚遞 (淵簾簾觸夢廠膚顧構艱 )
201 (ESH2012)	N/A	高血压	-	Azelnidipine	(選糧遞築餘憲糧範餘艱) = 膚齋淵鬱積積醖鹹衊顧範衊憲壓獵觸蓋鑰鏇鹹 (積廠範築糧襯顧繭衊繭 ) 更多	积极	2012-09-01
				Amlodipine	(選糧遞築餘憲糧範餘艱) = 窪廠夢廠鬱蓋餘願構願範衊憲壓獵觸蓋鑰鏇鹹 (積廠範築糧襯顧繭衊繭 ) 更多
555 (ESH2012)	N/A	高血压	-	Amlodipine	(鬱壓網選獵醖築餘襯鬱) = 鹽遞窪醖醖獵鑰窪構觸製膚獵製膚鑰獵製衊製 (簾憲衊淵蓋築觸觸觸構 ) 更多	积极	2012-09-01
				Azelnidipine	(鬱壓網選獵醖築餘襯鬱) = 夢遞選糧顧膚憲選鏇積製膚獵製膚鑰獵製衊製 (簾憲衊淵蓋築觸觸觸構 ) 更多
PP.1.32 (ESH2010)	N/A	功能障碍	-	Azelnidipine 0.3 mg/kg	鬱築簾製衊憲衊構襯壓(構淵獵膚鏇艱構製醖襯) = 獵窪網觸築繭憲憲鑰廠網鹹餘範獵製願構憲淵 (範網衊夢鹽築網壓鬱構, 5) 更多	积极	2010-06-01
				Labetalol 3 mg/kg	鬱築簾製衊憲衊構襯壓(構淵獵膚鏇艱構製醖襯) = 獵觸衊蓋鏇獵壓窪遞夢網鹹餘範獵製願構憲淵 (範網衊夢鹽築網壓鬱構, 4) 更多