Validated Reversed‐Phase HPLC Method for the Determination of Atenolol in the Presence of Its Major Degradation Product

Ceresole, Rita; Moyano, María Alejandra; Pizzorno, M. T.; Segall, Adriana Inés

doi:10.1080/10826070600983393

Cited by 19 publications

(11 citation statements)

References 24 publications

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“…The test resulted in mean recovery of 99.8% ± for amlodipine and 99.5% ± for atenolol and showed acceptable accuracy. The mean recovery was in good agreement with the published data for amlodipine (12) and atenolol (13,14). Limit of detection (LOD) was found to be 3.63 and 5.31 mg mL -1 for amlodipine and atenolol, respectively.…”

Section: Validation Of the Hplc Methodssupporting

confidence: 88%

“…However, data on the stability of such products are not disclosed and remain mostly with the manufacturer. As the combination of amlodipine and atenolol is not official in the therapeutic Compendia, quantitative analyses of amlodipine (6,11,12) and atenolol (13,14) in pharmaceutical dosage forms are generally described by UV spectrophotometric and high performance liquid chromatographic techniques. Determination of both components in multi-drug tablets is done by various methods such as UV spectrophotometry, HPLC, and HPTLC (15,16).…”

Section: Resultsmentioning

confidence: 99%

“…The chromatographic results of the standard with and without addition of the excipients were compared and no changes were observed after addition of excipients. It is known that atenolol can be determined in the presence of its major degradation product (14) and therefore the measurements were focused on drugs content alone. …”

Section: Validation Of the Hplc Methodsmentioning

confidence: 99%

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Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Aryal¹,

Škalko‐Basnet²

2008

Acta Pharmaceutica

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Fixed-dose drug combination decreases the risk of patient non-compliance and should be considered in patients with chronic conditions like hypertension (1). Clinically, combination therapy in hypertension treatment involving two or more drugs from different classes can result in better drug efficacy and is recommended for the initial stage of hypertension treatment (2). The combination of atenolol and amlodipine significantly decreases blood pressure and systolic blood pressure variability. In spontaneously hypertensive rats, the synergistic effect between atenolol and amlodipine results in lowering and stabilizing of blood pressure (3). Both beta blockers and dihydropyridine calcium antagonist are widely used in the treatment of hypertension. Their combination is a logical choice and can also neutralize the side effects of each drug. Combination therapy is likely to be the optimal way to control blood pressure and reduce blood pressure Multi-drug tablets of amlodipine besylate and atenolol were prepared as either mono-layer (mixed matrix) or bi--layer tablets containing each drug in a separate layer by using similar excipients and processing. Each tablet batch was packed in strip and blister packs and kept under accelerated temperature and humidity conditions. The stability of two tablet and packaging types was compared by HPLC analysis after 0, 1, 3 and 4.5 months and expressed as the content of intact amlodipine and atenolol. The content of atenolol did not decline regardless of tablet and packaging type. Amlodipine content in bi-layer tablets decreased to about 95 and 88% when packed in strips and blisters, respectively. When prepared as mono-layer tablets, the content decreased to 72 and 32%, respectively. The study revealed that the bi-layer tablet formulation was more stable than the mono-layer type. Further, the stability was increased when the tablets were packed in aluminium strips as compared to PVC blisters.

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Section: Validation Of the Hplc Methodssupporting

confidence: 88%

Section: Resultsmentioning

confidence: 99%

Section: Validation Of the Hplc Methodsmentioning

confidence: 99%

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Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Aryal¹,

Škalko‐Basnet²

2008

Acta Pharmaceutica

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“…Literature survey revealed that AT or AM or HZ was individually determined or in combination with other drugs by high-performance liquid chromatography (HPLC) [12][13][14][15][16][17][18][19][20][21][22]. The ternary mixture of AT, HZ, and AM was only determined by reversed-phase liquid chromatographic methods in pharmaceutical formulations using cyanopropyl and C18 columns [23,24].…”

Section: Introductionmentioning

confidence: 99%

Eco-Friendly Simultaneous Chromatographic Determination of Amiloride Hydrochloride, Atenolol, and Hydrochlorothiazide in Urine

Albishri

El‐Hady

Tayeb

2015

Acta Chromatographica

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Summary. Pharmaceutical industry concerned recently with eco-friendly analytical methods to reduce the environmental pollution. The using of toxic organic solvents for the analysis of drugs is critical. In the current work, several simple and less costly approaches such as micellar and/or cyclodextrin liquid chromatography were discussed. A new eco-friendly and simple chromatographic analysis of the ternary mixture of amiloride hydrochloride (AM), atenolol (AT), and hydrochlorothiazide (HZ) in urine by hydroxypropyl-beta-cyclodextrin (HP-β-CD) bonded stationary phase was investigated. The experimental conditions were optimized and validated based on International Conference on Harmonization (ICH) Q2R1 guidelines to detect analytes by isocratic mobile phase of phosphate buffer (5.0 mmol L −1 , pH 7.0) in the presence of 0.5 mL min −1 flow rate, 25.0 °C, and 280 nm. Linearity, accuracy, and precision were found to be acceptable over the concentration range of 0.05-20.0 μg mL −1 for AM, 0.05-50.0 μg mL −1 for AT and 0.05-50.0 μg mL −1 for HZ. The proposed method was precise, selective, and sensitive enough for the routine analysis of ternary mixture at therapeutic urine levels. The inclusion complexation and the appendant hydroxyl groups of HP-β-CD were considered the main reasons for assisting in adequate separation of the drugs. On the other hand, the presence of kosmotropic phosphate ions could solubilize the protein and could strengthen the selective inclusion of drugs inside HP-β-CD cavity. Urinary excretion studies showed that the detection of drugs is possible up to 24 h after their ingestion.

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“…Several procedures for atenolol determination have been employed, for application in pharmaceutical and biological samples. These procedures include capillary electrophoresis [7][8][9][10][11] , HPLC [12][13][14][15][16][17] , liquid chromatography [18][19][20][21] , gas-liquid chromatography…”

Section: Introductionmentioning

confidence: 99%

Cerimetric Determination of Four Antihypertensive Drugs in Pharmaceutical Preparations

El‐Didamony

Erfan

2011

J. Chil. Chem. Soc.

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A sensitive spectrophotometric method is described for the determination of atenolol (ATE), timolol maleate (TIM), captopril (CPL) and diltiazem hydrochloride (DIL.HCl) in bulk drugs and in pharmaceutical preparations. The method is based on the oxidation of the studied drugs by a known excess of cerric (IV) in acid medium followed by determination of unreacted oxidant by adding a fixed amount of methyl orange dye (MO) and the increasing in absorbance is measured at 510 nm. In this method the amount of cerium (IV) reacted corresponds to drugs concentration. The experimental conditions were optimized. Regression analysis of a Beer's plot showed good correlation in the concentration ranges of 3.2-6.4, 8.0-18, 3.4-5.2 and 3.6-5.2 µg/ml for ATE, TIM, CPL and DIL.HCl, respectively. The calculated molar absorptivity values are 5.28×10 4 , 3.27×10 4 , 6.43×10 4 and 1.12×10 5 L /mol cm, respectively and the corresponding Sandell's sensitivity values are 5.043, 13.2, 3.381 and 4.024 ng/cm 2 , respectively. The limit of detection (LOD) and quantification (LOQ) are reported. No interference was observed from the additives and the applicability of the method was tested by analyzing the pharmaceutical preparations containing the investigated drugs. Statistical comparison of the results with those of official methods shows excellent agreement and indicates no significant difference in precision.

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Validated Reversed‐Phase HPLC Method for the Determination of Atenolol in the Presence of Its Major Degradation Product

Cited by 19 publications

References 24 publications

Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Eco-Friendly Simultaneous Chromatographic Determination of Amiloride Hydrochloride, Atenolol, and Hydrochlorothiazide in Urine

Cerimetric Determination of Four Antihypertensive Drugs in Pharmaceutical Preparations

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