Simultaneous Determination Of Amlodipine Research Articles

Simultaneous determination of amlodipine and lisinopril dihydrate using fourth derivative spectroscopy

A new fast and simple selective method for the simultaneous determination of lisinopril dihydrate and amlodipine in combined drugs was developed using the fourth derivative spectrum method, based on the zero-crossing-point technique for the determination of compounds in drugs. The wavelength values for lisinopril dihydrate and amlodipine in solvent medium were found to be (203, 207, and 231 nm) and (215, 254, and 277 nm), respectively, with the average obeying Beer’s law in the range of lisinopril dihydrate 2.0 to 45.0 µg/mL and amlodipine 2.0 to 35.0 µg/mL. Lisinopril dihydrate has molar absorptivity regions (9227.76-11700.28 L/mol.cm, 203 nm), (15320.74-20795.59 L/mol.cm, 207 nm), and (2207.60-3311.40 L/mol.cm, 231 nm), while amlodipine (5886.72-10914.96 L/mol.cm, 215 nm), (5518.8-6418.16 L/mol.cm, 254 nm) and (1676.08-1921.36 L/mol.cm, 277 nm). The recovery rate of lisinopril dihydrate in the pharmaceutical dosage forms range was 95.13 to 102.60% and amlodipine 95.14 to 102.80%. The results of the relative error showed that the interferences did not affect the method of estimating these compounds. The proposed method has been successfully applied to estimate pharmaceutical dosage forms.

Simultaneous Determination of Amlodipine and Irbesartan in their Pharmaceutical Formulations by Square-Wave Voltammetry.

Hypertension is one of the most important health problems in the world and irbesartan and amlodipine are used in combination in various dosages for the treatment of high blood pressure. The aim of this study is to develop a fast, easy, sensitive, accurate, and precise squarewave voltammetry method for simultaneous determination of irbesartan and amlodipine besylate from pharmaceutical formulations at a hanging mercury drop electrode. In the applied method, since both active substances gave a peak at different potentials, no interference occurred between them. In optimization studies, Britton-Robinson buffer of pH 8.0 was chosen, in which the most appropriate peak shape and maximum peak current were observed. At the same time, as a result of instrumental parameter optimization to obtain reproducible results, 6 mV for scan increment, 30 mV for pulse amplitude, and 50 Hz for frequency were found suitable. As a result of the calibration studies of the optimized method, linear working ranges were determined as 1.00-13.08 μg mL-1 for irbesartan and 5.83-16.51 μg mL-1 for amlodipine besylate. Limit of detection and limit of quantitation values were respectively calculated as 0.63 and 1.00 μg mL-1 for irbesartan and 0.50 and 1.98 μg mL-1 for amlodipine besylate. The results of precision values (RSD) ranged from 0.67% to 2.31% for irbesartan and 0.65% to 1.49% for amlodipine besylate. Accuracy values were calculated as -0.15% to 1.63% for irbesartan and -0.07% to 3.78% for amlodipine besylate. The results obtained from the recovery studies ranged from 101.05% to 102.78% and from 98.88% to 102.20% for amlodipine besylate and irbesartan, respectively. After the validation studies of the developed method were carried out, it was successfully applied to pharmaceutical formulations containing these active substances.

Simultaneous Determination of Amlodipine and Valsartan in Tablet By UV Spectrophotometry With Successive Ratio Method

Objectives: This study aims to develop a spectrophotometric method by successive ratio method in simultaneous determination of AML and VLS on tablet preparations without separation.
 Methods: This study aims to develop a spectrophotometric method by successive ratio method in simultaneous determination of AML and VLS on tablet preparations without separation and then tested for validity based validation parameters, namely linearity, accuracy, precision, LOD and LOQ and intraday and interday. Then, this method was applied to determine the levels of AML and VLS on dosage tablet.
 Result: Manipulating the ratio spectra of the binary mixture allowed their determination at 358,4 nm and 247,4 nm and in the concentration ranges of (4-12 µg/mL) and (6-18 µg/mL) for amlodipine and valsartan, respectively
 Conclusion: The successive ratio method can be used to determine the levels of a mixture of amlodipine and valsartan drugs.

Simultaneous Determination of Amlodipine and Olmesartan Using HPLC with Fluorescence Detection

Simultaneous Determination of Amlodipine and Olmesartan Using HPLC with Fluorescence Detection

Simultaneous Determination of Amlodipine, Losartan, and the Losartan Carboxylic Acid Active Metabolite in Human Plasma by LC-MS/MS

Simultaneous Determination of Amlodipine, Losartan, and the Losartan Carboxylic Acid Active Metabolite in Human Plasma by LC-MS/MS

Highly Sensitive and Selective Electrochemical Sensor Based on Polyglycine Modified Glassy Carbon Electrode for Simultaneous Determination of Amlodipine and Ramipril from Biological Samples

In this study, the electrochemical behavior of the antihypertensive drugs amlodipine (AML) and ramipril (RAM) was investigated on polyglycine modified glassy carbon electrode (Poly(Gly)/GCE) as simultaneously. A simple and highly sensitive differential pulse adsorptive stripping voltammetric (DPAdSV) technique was developed for the simultaneous electrochemical determination of AML and RAM in 0.1 M H2SO4 solution (pH 1.0). The oxidation process of both analytes was found to be irreversible and exhibited mixed diffusion under adsorption-controlled process. The oxidation mechanism of drugs was proposed using the obtained data and discussed. The Poly(Gly)/GCE showed an enhancement effects on the oxidation current of AML and RAM with the significant peak potential differences of 0.52 V by AdSDPV technique. At the optimum conditions, the proposed method exhibited linear responses in concentration ranges 0.5–25 μM for AML and RAM with the detection limits of 0.08 and 0.130 μM, respectively. Finally, the proposed sensor was successfully applied for the sensitive detection and simultaneous determination of AML and RAM in human serum and human urine samples.

Simultaneous Determination of Amlodipine and Hydrochlorothiazide in Pharmaceutical Preparations by Differential Pulse Voltammetry Method

Objectives: In this study, a new, fast and reliable differential pulse voltammetry (DPV) method was developed and validated for the simultaneous determination of amlodipine (AML) and hydrochlorothiazide(HCT) in pharmaceutical preparations. Methods: Electrochemical behavior and simultaneous voltammetric determination of AML and HCT were investigated using glassy carbon electrode. Validation parameters such as specificity, linearity, accuracy, precision, ruggedness, stability, limit of quantification and limit of detection were studied according to the International Conference on Harmonisation (ICH) Guidelines. Results: The linearity of this developed method was established in the concentration range of 2.5-30 μg/mL for AML and HCT, respectively. The precision was less than 5.34 and 2.91 %, determined from quality control samples for AML and HCT, and accuracy was within 2.57 and 3.60 % in terms of relative error, respectively. The percentage recovery obtained for AML and HCT in pharmaceutical preparations were 99.6 and 100.1 %, respectively. Limits of detection and quantification for AML and HCT were 0.80 and 2.40 µg/mL, respectively. Conclusion: The developed DPV method can be used for routine analysis of AML and HCT in pharmaceutical preparations.

Simultaneous Determination of Amlodipine and Rosuvastatin in Pharmaceutical Preparations by Square Wave Voltammetry

Objectives: In this work, a new, rapid, simple, precise and specific method has been developed for the simultaneous determination of amlodipine (AML) and rosuvastatin (ROS) in pharmaceutical preparations by square wave voltammetry (SWV). Methods: Electrochemical behavior and simultaneous voltammetric determination of AML and ROS were investigated using platinum disk electrode. Validation parameters such as specificity, linearity, accuracy, precision, ruggedness, stability, limit of quantification and limit of detection were studied according to the ICH Guidelines. Results: The linearity of this developed method was established in the concentration range of 5-40 μg/mL for AML and ROS, respectively. The precision was less than 1.88 and 1.93%, determined from quality control samples for AML and ROS, and accuracy was within 1.69 and 1.97% in terms of relative error, respectively. The percentage recovery obtained for AML and ROS in pharmaceutical preparations were 99.5 and 100.2%, respectively. Limit of detection and quantification for AML were 0.70 and 2.10 µg/mL, for ROS 0.80 and 2.40 µg/mL, respectively. Conclusion: The developed SWV method can be used for routine analysis of AML and ROS in pharmaceutical preparations.

Development of methodology for of simultaneous determination of amlodipine, captopril and bisoprolol identification in dosage forms

Topicality. During the sample preparation and chromatographic separation thin layer chromatography (TLC) plays important role. Thin layer chromatography, or TLC, is a method for analyzing mixtures by separating the compounds in the mixture. TLC can be used to help determine the number of components in a mixture, the identity of compounds, and the purity of a compound. For treatment of hypertonic disease almost uses not mono-theraphy but combination of different pharmacological group of medicines. Aim. To improve to more rapid, simple, selective, more accurate, less expensive methods TLC analysis of simultaneous determination of amlodipine, captopril and bisoprolol and for using this method of analysis for development of bioanalytical methods. Materials and methods. The present study is assessed mobile phases of amlodipine, captopril and bisoprolol for thin layer chromatography. Results and discussion. Method of simultaneous identification of amlodipine, captopril and bisoprolol by TLC has been developed. Established that the most optimal Rf observed using mobile phases: ammonia (25 %)-propanol (30 : 70). We have explored the validation characteristics – specificity and suitability of the chromatographic system that met, the eligibility criteria established by the SPU. Conclusions. We have been developed chromatographic methods for simultaneous determination of amlodipine, captopril and bisoprolol. Propects for future research will be aimed at developing bioanalytical methods of analysis.

Simultaneous determination of valsartan, amlodipine besylate and hydrochlorothiazide in tablets by near infrared

Interval partial least-squares calibration (iPLS) and synergical partial least-squares calibration (siPLS) methods in combination with near infrared spectroscopy coupled with integrating sphere (NIRA) have been developed for simultaneous determination of amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCT) in raw material powder mixtures used for production commercial pharmaceutical product (tablets). Variable selection methods (iPLS and siPLS) were applied to select a spectral range that provided the lowest prediction error in comparison to the full-spectrum model. Spectral data were recorded between 10000 and 4000 cm-1 by NIRA and subdivided into 32 intervals. A relative standard error of prediction (RSEP) of 1.27% for VAL, 1.92% for HCT and 5.19% for AML was obtained after selection of better intervals by siPLS. Results shown that multivariate regression model associated to NIRA is a relatively simple, free-solvent and non-destructive procedure that could be applied to the simultaneous determination of AML, VAL and HCT in routine quality control of pharmaceuticals.

Oxidação Eletroquímica de Anlodipino e Hidroclorotiazida Sobre o Eletrodo de Diamante Dopado com Boro: Potencialidade de Determinação Simultânea em Urina

The present study was undertaken to evaluate the use of boron-doped diamond electrode in the simultaneous voltammetric determination of antihypertensives amlodipine and hydrochlorothiazide in urine sample. Two very well-resolved and reproducible oxidation peaks of amlodipine and hydrochlorothiazide, with separation of 0.360 V, were obtained in Britton-Robinson buffer (pH 5.0). Under the optimum analytical experimental conditions, the square-wave voltammetric method exhibited linear responses for simultaneous determination of amlodipine and hydrochlorothiazide in the concentration range 1.0 × 10 −7 – 2.1 × 10 −6 mol L −1 and 2.0 × 10 −6 – 2.2 × 10 −5 mol L −1 , with detection limits of 5.6 × 10 −8 mol L −1 and 1.6 × 10 −7 mol L −1 , respectively. The proposed method was applied in the simultaneous determination of amlodipine and hydrochlorothiazide in urine sample . DOI: http://dx.doi.org/10.17807/orbital.v7i1.673

English

English

HPTLC method for simultaneous determination of amlodipine besylate and enalapril maleate in pharmaceutical formulation

A rapid and simple high performance thin layer chromatography (HPTLC) method with densitometry at ?= 223 nm was developed and validated for simultaneous determination of Amlodipine and Enalapril from pharmaceutical preparation. Separation was performed on aluminum-backed silica gel 60F 254 HPTLC plates as stationary phase and using a mobile phase comprising of Toluene: Isopropanol: Glacial acetic acid (GAA): Methanol (6: 2: 0.6: 0.5 v/v/v/v) and 20 ml of mobile phase was used per chromatography run. After development, plates were observed under UV light. The validated lowest limit of detection was 80ng/spotand 200ng/spot whereas lowest limit of quantification was 150ng/spot and 400ng/spotfor Amlodipine and Enalapril respectively. The percentage assay of Amlodipine and Enalapril was found between 99.74 to 100.66% and 99.89 to 100.42% respectively. The described method has the advantage of being rapid and easy. Hence it can be applied for routine quality control analysis of Amlodipine and Enalapril from pharmaceutical preparation and stability studies.

Liquid Chromatography-Electro Spray Ionization Tandem Mass Spectrometry for Simultaneous Determination of Amlodipine, Benazepril and its Active Metabolite Benazeprilat in Human Plasma

A selective, sensitive, rapid, and reproducible liquid chromatographyelectro spray ionization tandem mass method has been developed and subsequently validated for the simultaneous determination of Amlodipine (AML), Benazepril (BENZ), and its active metabolite Benazeprilat (BENZT) in spiked human plasma, using Moexipril (MOX) as an internal standard (IS). Various modes were tried and the Multiple Reaction Monitoring (MRM) mode was found the most suitable one. The three analytes and Moexipril (IS) were extracted from human plasma by simple protein precipitation using acetonitrile as the precipitating solvent. The stationary phase used was a C18 Sunfire column while water and acetonitrile at 0.1 % formic acid (30:70, v/v) was used as a mobile phase. The flow rate used was 0.8 mL/min. FDA guidelines were followed for the method validation. The linearity range was found to be 10-200 ng/mL for Amlodipine, 0.5-100 ng/mL for Benazepril and 5-200 ng/mL for Benazeprilat and the correlation coefficient was more than 0.9980 for each analyte. The equation of the calibration curve was: y=0.0068x - 0.0072 (r2=0.9981, n=3) for Amlodipine, y=0.6098x - 0.135 (r2 =0.9988, n=3) for Benazepril and y=0.0173x - 0. 0312 (r2=0.9987, n=3) for Benazeprilat. Results for accuracy and precision showed satisfactory results. Also the method was compared with reported HPLC method and no significant difference was found.

Electro‐oxidation and simultaneous determination of amlodipine and atorvastatin in commercial tablets using carbon nanotube modified electrode

Amlodipine besylate and atorvastatin calcium have been determined by the simultaneous voltammetric method at a multi-walled carbon nanotubes:graphite (MWCNTs:G) paste electrode. In comparison with a glassy carbon electrode, the prepared electrode showed an increase in the peak current because of the high electroactive surface area and excellent electronic conductivity of MWCNTs. The dependence of currents and potentials on pH were investigated for these components at the surface of the MWCNTs:G paste electrode. Differential pulse voltammetry was applied as a sensitive technique for simultaneous determination of the drugs in commercial tablets. By anodic differential pulse voltammetry, the calibration plot was linear in the range of 2.5-100 μg/ml with standard deviation between 2.7-7.1 and 1.8-8.3% for amlodipine and atorvastatin, respectively. The detection limit was 1 μg/ml at the prepared electrode in the buffered solution pH 6.

Simultaneous Determination of Amlodipine and Aliskren in Tablets by High-Performance Liquid Chromatography

A new, simple, rapid and specific reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for the simultaneous determination of amlodipine besylate and aliskiren hemifumarate. The HPLC separation was achieved on an RP-18 column (250 × 4.6 mm) using a mobile phase of triethylamine-orthophosphoric acid buffer (50 mM, pH 3.0), acetonitrile and methanol (50:40:10, v/v/v) at a flow rate of 1 mL/min. The method was validated for specificity, linearity, precision, accuracy and robustness. The degree of linearity of the calibration curves, the percent recovery values of amlodipine and aliskiren and the limits of detection (LOD) and quantification (LOQ) for the HPLC method were determined. The linearity of the method was found to be in the concentration range of 5.0-50.0 µg/mL for aliskiren hemifumarate and 2.65-26.50 µg/mL for amlodipine besylate, LOD and LOQ values were 0.51, 0.95, 1.70 and 3.18 µg/mL for amlodipine besylate and aliskiren hemifumarate. The proposed method was successfully applied to amlodipine besylate and aliskiren hemifumarate in pharmaceutical dosage mixtures without any interference from the excipients. The method was found to be precise, accurate, reproducible and robust. The results agreed with those obtained using the developed reference method.

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Valsartan Tablets by Validated HPLC

A stability indicating LC method was developed for simultaneous determination of amlodipine and valsartan in pharmaceutical dosage form. Efficient chromatographic separation was achieved on C8 stationary phase with simple combination of mobile phase-A (70 : 20 : 10 v/v/v of water : acetonitrile : methanol with 2 mL of Octylamine adjusted the pH to 2.50 + 0.05 with orthophosphoric acid) and mobile phase-B (Acetonitrile) delivered in gradient mode. Quantification was carried out using ultraviolet detection at 240 nm at flow rate of 1.0 mL/min with Injection Volume of 100 μL and ambient column temperature. This method was capable to detect both the drug components of Amlodipine and Valsartan in presence of their degradation products (Amlodipine Imp-A and Valsartan Impurity-B) with the detection level of 0.05%. Amlodipine/Valsartan and their combination drug product were exposed to thermal studies, photolytic, hydrolytic and oxidative stress conditions, and samples analysed. Peak homogeneity data of Amlodipine and Valsartan is obtained using PDA detector, demonstrating the specificity. The method shows excellent linearity over range of 0.05–2.0% for Amlodipine; Amlodipine Impurity-A and 0.05–1.0% for Valsartan and Valsartan Impurity-B. The correlation coefficient for Amlodipine and Valsartan are 0.9999. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of Amlodipine and Valsartan in pharmaceutical preparations.

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.

SIMULTANEOUS DETERMINATION AND PHARMACOKINETIC STUDY OF AMLODIPINE AND VALSARTAN IN RAT PLASMA USING ION-PAIR HPLC WITH FLUORESCENCE DETECTION

A simple, selective, and sensitive high-performance liquid chromatographic method is described for the simultaneous determination of amlodipine and valsartan combined tablets in rat plasma, using losartan as internal standard. The assay was based on protein precipitation with acetonitrile then reversed phase chromatography with fluorescence detection. In order to delay the rapid elution of amlodipine and to obtain acceptable relative retention value, sodium hexane sulfonate was used as ion pairing reagent and a gradient elution mode was applied. The separation was performed on an Agilent Zorbax Eclipse XDB C18 column, using gradient elution with aqueous 0.02% sodium hexane sulfonate–glacial acetic acid (500:1,v/v) (solvent A) and acetonitrile (solvent B). The fluorescence detector was on-line switched to measure each analyte and internal standard at their optimum excitation and emission wavelengths. The assay was linear over the concentration ranges 0.01–0.80 and 0.10–20 µg/mL for amlodipine and valsartan, respectively, with recoveries of 97.80 and 99.35%, respectively. The method was successfully applied to a pharmacokinetic study involving a single oral dose of combined (10/160 mg) tablet.

Simultaneous determination of amlodipine and atorvastatin with its metabolites; ortho and para hydroxy atorvastatin; in human plasma by LC–MS/MS

A simple liquid chromatography/ion trap mass spectrometry method for the quantification of amlodipine and atorvastatin with its metabolites, ortho and para hydroxy atorvastatin, simultaneously in human plasma was developed. Analytes with internal standard were extracted by protein direct precipitation with acetonitrile. Adequate chromatographic separation was achieved using Phenomenex Synergi 4u polar-RP 80A (150mm×4.6mm, 4μm) column in the isocratic elution mode and the eluent was water/methanol (14:86%, v/v) adjusted by trichloroacetic acid to pH 3.2 which was delivered isocratically at constant flow rate of 0.50mL/min. Standard solutions for the analytes were prepared using amlodipine besylate, atorvastatin calcium, ortho-hydroxy atorvastatin dihydrate monosodium salt, para-hydroxy atorvastatin disodium salt, and pravastatin sodium as an internal standard. The method validation intends to investigate specificity, sensitivity, linearity, precision, accuracy, recovery, matrix effect and stability according to USFDA guideline. Standard calibration levels were prepared by pooled human plasma to attain final dynamic range of 0.2-20.0ng/mL for amlodipine, 1.5-150ng/mL for atorvastatin, 1.0-100.0ng/mL for ortho-hydroxy atorvastatin and 0.2-20.0ng/mL for para-hydroxy atorvastatin. Clinical bioequivalence study was successfully investigated by the application of this validated bioanalytical method in order to evaluate bioequivalence of two commercial products 10mg amlodipine/80mg atorvastatin in a single dose. In this study, 29 healthy volunteers were participated in randomized, two periods, double blend, open label cross over design. Pharmacokinetic parameters of C(max), AUC(0-t) and AUC(0-∞) were calculated to compare a test product with CADUET(®) reference product.