No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
SIMPLE VALIDATION OF AZELNIDIPINE BY RP-HPLC METHOD
... [8,9] The dose of AZE is about 16 mg/day. After reviewing the literature, it can be said that for AZE, very limited techniques are available to estimate the concentration of AZE, including high-performance liquid chromatography, [10][11][12][13] liquid chromatographymass spectrometry (LC-MS), [14,15] high-performance liquid chromatography mass analysis capabilities of mass spectrometry (HPLC-MS-MS), [16] UV spectroscopy. [17] The TEL (Fig. 2) an oral AT-II specific receptor antagonist with chemical formula 2-(4-{[4-methyl-6-(1-benzodiazol-1-yl] methyl} phenyl) benzoic acid with a longer duration of action and long half-life. ...
The present investigation deals with the reverse phase high performance liquid chromatography (RP-HPLC) method validation for simultaneous estimating Azelnidipine and Telmisartan in a fixed-dose combination (FDC). The method was developed using RP-HPLC, Inertsil C-18 Column with 150×4.6 mm×5 µm at column oven temperature 40°C, flow rate 1.5 mL/min, volume 10 µL and run time 12.0 minutes at 254 nm using Acetonitrile and buffer as mobile phase in gradient mode. The developed protocol was most accurate, repeatable, and detectable towards Azelnidipine and Telmisartan in combination without any unwanted interference. When evaluated on various parameters like system suitability, precision, accuracy, linearity, robustness, force degradation study, the method is efficient in separating the API from its degradants and can be utilized for analyzing the samples of Azelnidipine and Telmisartan.
As part of this study, a new sensitive, convenient, accurate and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the determination of azelidipine in pharmaceutical and tablet formulations was developed and validated. The three variables chosen were methanol concentration, flow rate, and pH in the mobile phase. Separation was performed using an HPLC method with a UV detector and a Chromosil C18 (250mm x 450mm). Methanol was pumped at a flow rate of 1.0mL/min and adjusted to pH 4.0 with dilute OPA (60:40% v/v) and pH 4.0 with potassium dihydrogen phosphate buffer (pH 4.0), 255nm.
Background:
Diabetes, high cholesterol, and high blood pressure all considerably raise the risk of cardiovascular disease. When all three of these characteristics occur at once, a metabolic problem is postulated. A combination of antihypertensive, hypolipidemic, and anti-diabetic medications is frequently utilised to treat cardiovascular diseases. While statins (fluvastatin, simvastatin, etc.) are used to lower cholesterol levels, calcium channel blockers (e.g. amlodipine, efonidipine, and azelnidipine, etc.) are used to target the smooth muscles of the heart. Diuretics (e.g. chlortalidone, hydrochlorothiazide, etc.) and angiotensin II receptor antagonist (blockers) are also used to manage high blood pressure.
Objective:
The study aimed to review liquid chromatography and related high-performance (HPLC) techniques that have been developed and used for evaluating the above drugs, together with an overview of the research work published in various scientific and drugs-linked journals.
Results:
A basic critical investigation of the detailed published information has been completed and the current status of HPLC and related techniques as a percent measure of calcium channel blockers has been examined.
Conclusion:
This survey has explored several matrices, including pharmacological products and organic samples, as well as methods for examining direct calcium blockers in them. It also discusses the current state of calcium channel blocker stability investigations. Additionally, it offers scientific approaches for the concurrent estimate of angiotensin II receptor antagonism, diuretics, statins, and beta-blockers with calcium channel blockers.
The objective of this work is to develop a rapid, precise, accurate and sensitive Reverse Phase High Performance Liquid Chromatographic method and U. V. Spectroscopy for the determination of Azelnidipine in Bulk and pharmaceutical dosage form. The chromatographic method was Standardized for Azelnidipine using Shimadzu HPLC model reverse phase analytical inspire C18 column (250 mm x 4.5 mm, 5 μm particle size) with LC10AD pump and PDA detector. The separation was carried out by using a mobile phase containing Methanol 70 ml and Water 30 ml (0.1% Gaa) PH adjust 6.5 by o-phosphoric acid pump at flow rate 1.0 ml/min with detection at 256 nm. The retention time of Azelnidipine found to be 4.6 min. The method was shown to be linear in 10-50µg/ml concentration range (regression coefficient of .9982). The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0071 µg/ml and 0.0218 µg/ml respectively. The method was to be precise with % RSD value 0.14 and 0.17 for intraday and interday respectively.
An analytical method based on reverse phase-high performance liquid chromatography (RP-HPLC) has been developed and subsequently validated, which was found to be simple and rapid for the simultaneous quantification of azelnidipine and telmisartan in pharmaceutical dosage form. The separation was performed on an Intersil C18 column (250 × 4.6mm, i.d., 5µm) utilizing the mobile phase having composition 70 volumes of acetonitrile and 30 volumes of 5 millimolar phosphate buffer pH 4.6. The chromatographic analysis was carried on isocratic elution at a flow rate of 1mL/min. Detection was carried out with UV detector at 255nm, and linearity was found at concentration ranges of 10-50µg/ml for AZL and 20-100µg/ml for TEL. The recoveries obtained were 99.48‒100.22% for AZL, and 99.62 – 99.88% for TEL. No interference was found by the excipients in the formulation. The method was validated as per guidelines framed by International conference of harmonization for the parameter accuracy, precision, specificity, robustness, limits of detection and quantitation. The developed RP-HPLC method was applied in the analysis of commercial pharmaceutical products containing AZL and TEL and found to be efficient from recovery results.
The aim of this study is to develop and validate an accurate, sensitive, rapid, precise, and simple bioanalytical method for the estimation of Azelnidipine (calcium channel blocker, used in hypertension) in the human plasma by using LC-ESI-MS/MS. The method was developed by gradient conditions using 0.1% Formic Acid in Acetonitrile and Milli-Q water with 10mM Ammonium acetate as a mobile phase with a flow rate of 0.5 mL/min. The Analyte and IS (Metoprolol) were separated by using a C18 Phenomenex Kinetex (50x3mm, 5µ) column. 7.0 minutes was the chromatographic run time. The analyte and IS extracted from plasma by simple protein precipitation technique (PPT). The LOD and LLOQ were found to be 0.53125ng/mL and 1.0625ng/mL, respectively. The extraction recovery of the drug from plasma was high. The other validation parameters were found within the range, as mentioned by USFDA and EMA guidelines.
Backgroound
Products with multiple active substances mixed in a single dosage form are fixed-dose combinations. These are justified for a variety of reasons. These include a) increasing therapeutic efficacy, b) lowering adverse drug effects, c) pharmacokinetic advantages, d) lowering pill load, e) lowering individual drug doses, and f) lowering drug resistance development.
Objective
A recently approved fixed dose combination of azelnidipine (8 mg) and chlorthalidone (6.25 or 12.5 mg) is indicated to treat hypertension. Individual quantification methods for azelnidipine and chlorthalidone are available, but no practical and acceptable analytical approach for their combination has been documented. As a result, the goal of this literature review was to gather information on the numerous analytical instrumental approaches utilized to quantify azelnidipine and chlorthalidone in diverse matrices individually. The scientific community could use this information to design a new analytical method for analysing the recently approved combination.
Methods
Authors have explored various scientific databases to obtain information on analytical methods.
Results
The methods listed for azelnidipine and chlorthalidone are spectroscopy, high-performance liquid chromatography, hyphenated techniques, high-performance thin-layer chromatography, thin-layer chromatography, and a few other approaches. For azelnidipine and chlorthalidone, there were 26 and 46 research papers reported, respectively.
Azelnidipine (AZEL) is chemically (±)-3-(1-diphenylmethylazetidin3-yl) 5-isopropy12-amino-1, 4-dihydro-6-methyl-4-(3-nitrophenyl) 3,5-pyridinedicarboxylate. It is a dihydropyridine (DHP) type of calcium channel blocker (CCB) used for the treatment of hypertension. AZEL has two enantiomers due to an asymmetric carbon at the 4-position of the DHP ring. The pharmacological action of AZEL resides in the (R)-enantiomer. This is in marked contrast to other CCBs in which the (S)-enantiomer is responsible for the biological activity. The peculiar three-dimensional structure of the active enantiomer of AZEL may be related to its unique pharmacological features that are not shared by other DHPs such as long lasting reduction in blood pressure, decreased heart rate and antiatherosclerotic effect. AZEL also shows diuretic effect by increasing urine volume and thus reduction in retention of ions. Some analytical methods for the quantitative determination of Azelnidipine in pharmaceutical formulations like UV, LCMS/MS, RP-HPLC, HPLC-MS/MS, UFLC, LC-ESI-MS
ResearchGate has not been able to resolve any references for this publication.