Method For Determination Of Amlodipine Research Articles

Sustainable and white HPLC method for simultaneous determination of amlodipine and atorvastatin in film-coated tablet

This study presents a collaboration between academia and the pharmaceutical industry with one goal, to implement the transformation of the conventional into sustainable HPLC methods and to use these methods in the routine quality control of medicines. Therefore, a sustainable, fast, and robust high-performance liquid chromatography (HPLC) method for the determination of amlodipine (AML) and atorvastatin (ATV) in film-coated tablets was developed. The chromatographic separation was performed on stable bond C8 column (150 × 4.6 mm, 5 μm), using a mixture of ethanol and 0.02 M sodium dihydrogen phosphate monohydrate, pH 3.0 (63:37%, v/v) as a mobile phase. The optimized conditions enabled the determination of AML and ATV within 5 min, providing satisfactory results for system suitability parameters. The method was validated in accordance with the ICH guideline in terms of specificity, linearity, accuracy, and precision (repeatability and intermediate precision). The robustness of the method was confirmed using the Plackett-Burman experimental design. The greenness features of the method were assessed using the Eco-scale index, the AMGS calculator, and the AGREE tool. The high value of the whiteness score (93.5) confirmed that the method meets the requirements for the three main pillars (analytical, ecological, and economical) for the sustainable method development. The method was applied for the determination of both analytes in pharmaceutical dosage form (film-coated tablets that contains 10 mg AML and 10 mg ATV).

Development and validation of analytical method for determination of amlodipine and benazepril in bulk and pharmaceutical dosage form by RP-HPLC

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Amlodipine and Benazepril, in its pure form as well as in capsule dosage form. Chromatography was carried out on an Altima C18 (4.6 x 150 mm, 5µm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 225 nm. The retention time of the Amlodipine and Benazepril was 2.102, 3.537 ±0.02 min respectively. The method produce linear responses in the concentration range of 5-25 mg/ml of Amlodipine and 20-100 mg/ml of Benazepril. The method precision for the determination of assay was below 2.0 %RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Opportunities of Amlodipine as a Potential Candidate in the Evaluation of Drug Compliance during Antihypertensive Therapy.

Background and Objectives: Blood pressure measurement is essential evidence to establish that the chosen medicine and dosage are appropriate, and also indirectly indicates whether the medicine is being used at all. Therefore, current research compares adherence to the target blood pressure at home and in the hospital between different age groups, using similar combinations of the drugs prescribed by the doctor within ongoing antihypertensive therapy. Moreover, it is very important to develop a method for the determination of amlodipine and its metabolite, which would suitable for clinical applications, when the result is needed as quick as possible. Materials and Methods: This prospective study included patients aged ≥18 years who were diagnosed with hypertension. Subjects were divided into two age groups according to European Society of Cardiology (ESC) hypertension guidelines; older patients (≥65 years) and adult patients (<65 years). Assessment of adherence rate to antihypertensive medications was performed using a measurement of systolic blood pressure and comparing this to ESC hypertension guideline data. A simple liquid chromatography-tandem mass spectrometer (LC-MS/MS) method for determination of amlodipine and dehydroamlodipine was developed and validated according to the European Medicines Agency guideline on bioanalytical method validation at the Latvian Institute of Organic Synthesis. Results: A total of 81 patients with arterial hypertension were enrolled in this study. A significant number of patients were overweight (N = 33, 40.7%) and obese (N = 36, 44.4%). To control arterial hypertension, 70 (86.4%) patients used fixed-dose combinations, where one of the components was amlodipine. Practically, 36 (44.4%) hypertensive subjects were not able to comply with target blood pressure. Nonetheless, 38 (46.9%) patients who received fixed-dose combinations were able to comply with target blood pressure. Conclusions: Adherence to ESC hypertension guideline proposed target blood pressure was relatively low among hypertensive subjects even though a significant number of patients were taking fixed-dose combinations. Therefore, optimizing prevention, recognition, and care of hypertensive young adults require intensive educational interventions. Moreover, survey data suggest that therapeutic drug monitoring using the validated simple, sensitive LC-MS/MS method is pivotal for further understanding factors influencing adherence.

Two different spectrophotometric methods for simultaneous determination of binary mixture of atenolol and amlodipine in commercial formulation

Two different spectrophotometric methods for simultaneous determination of binary mixture of atenolol and amlodipine in commercial formulation

Development and Validation of Liquid Chromatography - Tandem Mass Spectrometry Method for Determination of Amlodipine in Human Plasma and Its Application

Development and Validation of Liquid Chromatography - Tandem Mass Spectrometry Method for Determination of Amlodipine in Human Plasma and Its Application

Development and Validation of highly Sensitive Stability Indicating Spectrofluorimetric Method for Determination of Amlodipine in Pharmaceutical Preparations and Human Plasma.

A highly sensitive and simple spectrofluorimetric method was developed for the determination of Amlodipine besylate (AML) in its pharmaceutical formulations and spiked human plasma. The proposed method is based on the investigation of the fluorescence spectral behaviour of AML in Tween-80 micellar system. In aqueous solution, the fluorescence intensity of AML was greatly enhanced (160%) in the presence of Tween-80. The fluorescence intensity was measured at 427nm after excitation at 385nm. The fluorescence-concentration plot was rectilinear over the concentration range 0.1-4.0μg/ml, with lower detection limit of 0.03μg/ml. The suggested method was successfully applied for the analysis of AML in its commercial tablets alone or in combination with either Atorvastatin or Valsartan. The application of the proposed method was extended to the assay of AML in spiked human plasma and stability studies of AML after exposure to different forced degradation conditions, such as acidic, alkaline, photo- and oxidative conditions, according to ICH guidelines. The results were statistically compared to those obtained by comparison methods and were found to be in good agreement.

Development and Validation of Reversed Phase High Performance Liquid Chromatographic Method for Determination of Amlodipine

Purpose: To develop and validate a new sensitive and low-cost method for the analysis of amlodipine in tablet dosage form using reversed phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection.Methods: Standards and samples were prepared by dissolving amlodipine besylate standard or amlodipine tablets in mobile phase and sonicated for 5 min. The samples were analysed by RP-HPLC equipped with quaternary pump and auto-injector. Separation was achieved using C18 column, and the mobile phase consisted of ammonium acetate buffer containing 0.02 % triethylamine TEA (pH = 4, adjusted using glacial acetic acid) and acetonitrile in the ratio 60:40 v/v. The flow rate was 1 ml/min and a UV detector was used for the detection of amlodipine at a wavelength of 248 nm. The method was validated according to International Conference of Harmonization (ICH) guidelines.Results: The retention time for amlodipine peak was 3.44 ± 0.41 min with a total run time of 6 min. The method was linear over the range of 0.5 - 40 μg/ml with coefficient of determination (R2) of 0.999. Recovery was 98.09 - 100.19 %, and the method showed high precision and repeatability. All validated parameters were within the range of ICH requirements.Conclusion: A new rapid sensitive and low-cost method has been developed and validated for the analysis of amlodipine in tablet dosage form.Keywords: Amlodipine, Recovery, Repeatability, Precision, Reversed phase high performance liquid chromatography, Validation

A Validated Stability-Indicating RP-LC Method for the Simultaneous Determination of Amlodipine and Perindopril in Tablet Dosage Form and Their Stress Degradation Behavior Under ICH-Recommended Stress Conditions

A stability-indicating RP-LC assay method was developed for the simultaneous determination of the cardiovascular drugs amlodipine and perindopril in the presence of degradation products generated from forced decomposition studies. The developed method is applicable for the determination of related substances in bulk drugs and simultaneous assay in a tablet pharmaceutical dosage form. Separation of the drugs and their degradation products was obtained using an RP Waters Spherisorb ODS1 column (250 x 4.6 mm id, 5 pm particle size) with the mobile phase acetonitrile-water (30 + 70, v/v) containing 15 mM phosphoric acid. The pH of the mobile phase was adjusted to 5.0. A flow rate of 1.2 mL/min was used for the separations, with detection at 215 nm. The chromatographic separation was performed at a column temperature of 45 degrees C. Atenolol was chosen as the internal standard. Amlodipine and perindopril were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Degradation studies showed that both compounds were degraded under these stress conditions. The method was found to be stability-indicating and can be used for the routine analysis of amlodipine and perindopril in the studied combined tablet dosage form.

High-Performance Liquid Chromatographic Method for Quantitative Determination of Amlodipine in Human Plasma and Pharmaceutical Dosage Form and its Application to Pharmacokinetic Studies

An accurate, sensitive, and reproducible high-performance liquid chromatographic method for the quantitation of amlodipine besylate in human plasma has been developed and validated. The drug, internal standard, and major metabolite were eluted from a C(18) hypersil HyPurity column (3 microm, 3.9 mm i.d. x 150 mm) at room temperature with a mobile phase consisting of acetonitrile-potassium dihydrogen phosphate buffer (0.05 M) and acetic acid (62:38:0.1) with the pH adjusted to 3.5 using phosphoric acid. The flow-rate was 1.8 mL/min. The limit of detection was 1.0 ng/mL, and the limit of quantification of amlodipine besylate in plasma was 10 ng/mL. The intra- and inter-day precisions showed coefficients of variation ranging from 5.98-11.4% and from 5.60-11.74%, respectively at three different levels of concentration. The averages of the absolute and relative recoveries were found to be 96.74-98.51% and 95.96-100.71%, respectively. Stability studies showed that amlodipine besylate is stable for at least 2 months in plasma after freezing at -20 degrees C. The method was successfully applied for a pharmacokinetic study and for the determination of commercial amlodipine tablet content.

A Kinetic spectrophotometric method for determination of amlodipine and Nifedipine in pharmaceutical preparations

A simple, accurate, sensitive and economical procedure for the estimation of amlodipine besylate and nifedipine, both in pure and dosage forms, has been developed. The method is based on the reduction of iron(III) by the studied drugs and subsequent interaction of iron(II) with ferricyanide to form Prussian blue. The reaction develops through a slow kinetics and completes in about 10 min. Both initial slope and fixed time methods were used to derive calibration graphs. The resulted calibration equations were linear in the concentration ranges of 1.0-20.0 and 3.0-19.0 μg ml-1 for AML and NIF, and the detection limits were 0.10 and 0.19 μg ml-1, respectively. Seven replicate analyses of solutions containing three different levels of each drug resulted in very low relative error of prediction (less than 1.6%) and relative standard deviation (less than 4%) confirming accuracy and precision of the proposed method. The proposed method was applied to the determination of these drugs in pharmaceutical formulations and excellent recoveries were obtained.

Validated HPLC method for determination of amlodipine in human plasma and its application to pharmacokinetic studies

A rapid, simple and sensitive high-performance liquid chromatography (HPLC) method has been developed for quantification of amlodipine in plasma. The assay enables the measurement of amlodipine for therapeutic drug monitoring with a minimum detectable limit of 0.2 ng ml −1. The method involves simple, one-step extraction procedure and analytical recovery was about 97%. The separation was performed on an analytical 125 × 4.6 mm i.d. Nucleosil C 8 column. The wavelength was set at 239 nm. The mobile phase was a mixture of 0.01 M sodium dihydrogen phosphate buffer and acetonitrile (63:37, v/v) adjusted to pH 3.5 at a flow rate of 1.5 ml min –1. The calibration curve was linear over the concentration range 0.5–16 ng ml −1. The coefficients of variation for inter-day and intra-day assay were found to be less than 10%.

Simple and rapid HPLC method for determination of amlodipine in human serum with fluorescence detection and its use in pharmacokinetic studies

A fast, sensitive and specific high performance liquid chromatographic method using fluorescence detection is described for analysis of amlodipine in human serum. Amlodipine is extracted from serum by ethyl acetate and involves precolumn derivatization with 4-chloro-7-nitrobenzofurazan (NBD-Cl) and reverse-phase chromatography on C18 column. The mobile phase was sodium phosphate buffer (pH 2.5) containing 1 ml/l triethylamine and methanol at flow rate of 2.8 ml/min. Propranolol was used as internal standard. The standard curve was linear over the range 0.25–16 ng/ml of amlodipine in human serum. The within-day and between-day precision studies showed good reproducibility with coefficients of variation less than 12% for all the analytes. The limit of quantification was 0.25 ng/ml of serum. The method has been applied to a bioequivalence study after administration of 10 mg amlodipine in 12 normal subjects.

Enzyme linked immunosorbent assay for determination of amlodipine in plasma.

Amlodipine is a calcium channel antagonist of the dihydropyridine group. It is effective for treating hypertension, chronic stable angina, and vasospastic angina. However, it is difficult clinically to pinpoint the maximum dosage for antihypertensive activity of the drug without having parallel data on the plasma drug concentrations. The methods for assaying amlodipine are either gas chromatography with electron capture detector or liquid chromatography coupled with tandem mass spectrometry (or with an electrochemical detector), which needs tedious derivatization, and is expensive and time consuming. Therefore, in this study we developed an enzyme immunoassay for determining amlodipine in plasma. Anti-amlodipine antibodies were produced following immunization of bovine serum albumin-amlodipine conjugate. These specific antibodies were used in a competitive biotin-avidin-based enzyme-linked immunosorbent assay to measure amlodipine in plasma. Biotin was linked to the antibodies in order to enhance the sensitivity of the assay. The assay was specific for the free form of amlodipine with a detection limit of 0.1 ng/ml and the intra- and interassay coefficient of variation ranged from 1.6-10.2%. This immunoassay provides a sensitive, reliable, rapid, and accurate method for determination of amlodipine in plasma, which can be used in therapeutic drug monitoring pharmacokinetic studies and pharmaceutical analysis.