Analytical method development and validation of Amlodipine besylate in tablet dosage form

Kumar, Sunil; Ram, Bigan

doi:10.22270/jddt.v9i4-a.3459

Cited by 5 publications

(4 citation statements)

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“…The obtained results coincide with similar studies by other authors. In particular, spectrophotometric methods for determining pure albendazole and in the composition of solid and liquid dosage forms are sensifast, economically available and subject to validation [6][7][8][9][10][11][12]. In the simultaneous determination of albendazole and other anthelmintic agents, for example, ivermectin, other researchers often turn to LC, GLC, and HPLC [13][14][15][16][17].…”

Section: Discussionmentioning

confidence: 99%

Development and validation of a method for simultaneous quantitative determination of albendazole and praziquantel in coated tablets “AP-helmin”

Semchenko,

Vyshnevska,

Iakovenko

et al. 2024

ScienceRise: Pharmaceutical Science

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Adapting modern methods of quantitative analysis of active substances in their joint content in the dosage form and validating them is an integral process of pharmaceutical development. We have developed a drug in the form of coated tablets for the treatment of helminthiases of the digestive system in adults. A feature of this drug is the composition of the API of albendazole and praziquantel in a ratio of 1:4. The aim of this research is to develop methodology for quantitative analysis of both substances by the method of liquid chromatography, determination of their possible mutual influence on the process, as well as validation of the proposed methods. Materials and methods. To meet the research's set purpose, the following tasks were identified: choosing the most rational method for the quantitative determination of albendazole and praziquantel; confirming the absence of the mutual influence of APIs on the results obtained; and validating the selected methods of albendazole and praziquantel analysis. Object of the research conducted included coated tablets “AP-helmin”, series 1-5.2021; pharmacopoeial standard sample (PSS) of albendazole, and PSS praziquantel. Quantitative determination of albendazole and praziquantel was conducted according to SPU, method 2.2.29. Results. The article describes the conditions and stages of the quantitative determination of albendazole and praziquantel and the main indicators of method validation. Conclusions. It was proven that quantification with the liquid chromatography method of both substances is validated, and the substances do not affect each other's analysis in the coated tablets "AP-helmin" following the project of QCM for this drug. All calculated parameters meet the required validation criteria

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Section: Discussionmentioning

confidence: 99%

Development and validation of a method for simultaneous quantitative determination of albendazole and praziquantel in coated tablets “AP-helmin”

Semchenko,

Vyshnevska,

Iakovenko

et al. 2024

ScienceRise: Pharmaceutical Science

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“…Additional dilutions of the standard stock solution were made with the mobile phase and the UV spectrum was scanned to acquire spectra. It was found that both albendazole and its primary impurity, Oxibendazole, exhibited significant absorption at 235 nm [8].…”

Section: Detection Of Wavelengthmentioning

confidence: 99%

RP-HPLC method development and validation of Albendazole and its impurity

Saini,

Singh,

Vyas

et al. 2024

BIO Web Conf.

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Oxibendazole is a type of benzimidazole that is commonly used as an antiparasitic medication for both humans and animals. However, it is also a significant impurity found in albendazole, and it is crucial to follow the ICH Q3B criteria when analysing oxibendazole impurities. Therefore, it is recommended to use a simple, fast, sensitive, and precise RP-HPLC approach to identify oxibendazole impurities in bulk and pharmaceutical formulations of albendazole.To separate the oxibendazole impurity, acetonitrile and 10 nM potassium phosphate were used as a mobile phase. Orthophosphoric acid was used to accurately adjust the pH of the mobile phase to 2.03, ensuring optimal conditions. A nucleosil C18 column (250 x 4.6 mm, 5 µm) was used for the separation process, and it effectively provided the necessary separation. The gradient elution was set at a wavelength of 235 nm and a flow rate of 1 mL/min. The analytical technique was successfully designed and validated. The AQbD technique was used to optimize the analytical conditions for the suggested methodology, and the Design Expert 13® trial version was used for the central composite design optimization of analytical conditions. The procedure's linearity was verified using a regression coefficient of 0.999 within a working range of 0.5 to 3 μg/ml. Accuracy research showed results of 99.94–100.10% at 50, 100, and 150% levels of the working concentration. The oxibendazole impurity's average retention time was found to be 6.40 minutes, with a relative standard deviation of less than 2%, indicating high accuracy. The limits of detection (LOD) and quantification (LOQ) were found to be 0.073 and 0.091 μg/ml, respectively. Following the ICH Q2(R1) criteria, other validation criteria, such as robustness, were also evaluated. In conclusion, the proposed approach is suitable for analysing albendazole and oxibendazole in bulk and pharmaceutical formulations, making it ideal for detecting oxibendazole impurities.

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“…2 Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethox) methyl]-4-(2-chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedi carboxylate, mono benzene sulphonate. AML is a calcium channel blocker 2 , which inhibits the influx of extracellular calcium across the myocardial and vascular smooth muscle cell membranes, thus decreasing the contractile process and hence dilating coronary and systemic arteries 3 .…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination

Mistry¹,

Shah²,

Jat³

2022

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Introduction: Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodipine besylate (AML) is required in this type of patients.  Aim: A simple, selective and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in synthetic mixture.  Materials and methods: Chromatographic separation was performed on a reversed-phase Luna C18 100Å column (250 mm × 4.6 mm i.d., particle size 5 μ) using an isocratic elution of mobile phase consisting of methanol and acetonitrile (pH 3.5 adjusted by ortho-phosphoric acid) (60:40 v/v) at a flow rate of 1.0 ml/min.  Results: Ultraviolet (UV) detection was performed at 242 nm and retention time of telmisartan, rosuvastatin calcium and amlodipine besylate was found to be 2.67, 4.70, and 7.44 min, respectively. The calibration curve was linear (correlation coefficient >0.999) in the selected range of analyte.  Conclusions: The method was validated for accuracy, precision, linearity, limit of detection, limit of quantitation and ruggedness. The system suitability parameter, such as theoretical plate, asymmetry, and resolution between standard five replicate were well within the limits.  

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Analytical method development and validation of Amlodipine besylate in tablet dosage form

Cited by 5 publications

References 0 publications

Development and validation of a method for simultaneous quantitative determination of albendazole and praziquantel in coated tablets “AP-helmin”

Development and validation of a method for simultaneous quantitative determination of albendazole and praziquantel in coated tablets “AP-helmin”

RP-HPLC method development and validation of Albendazole and its impurity

RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination

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