HPLC Method for Determination of Aspirin, Rosuvastatin,
Ezetimibe and Clopidogrel in Combination Drug Products

Palacharla, Suresh Kumar; Mohan, G. Krishna

doi:10.14233/ajchem.2019.22050

Cited by 2 publications

(1 citation statement)

References 15 publications

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“…The sensitivity of the method for the detection of impurities in the darolutamide was confirmed by determining limit of detection (LOD) and limit of quantification (LOQ). The applicability of the developed Bulletin of the Karaganda University method for the detection and quantification of impurities in formulation was confirmed by analysing the formulation solution prepared from cream formulation of darolutamide (Nubeqa ® -300 mg) [15][16][17][18].…”

Section: Preparation Of Solutions: Darolutamide and Impurity Solutionsmentioning

confidence: 99%

Development and validation of a novel stability indicating HPLC method for the separation and determination of darolutamide and its impurities in pharmaceutical formulations

Kamani¹,

Sujatha²,

Daddala³

2021

Bull. of the Kar. Univ. "Chem". Ser.

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This study reports for the first time about a stability indicating RP-HPLC method for analysis of darolutamide and its impurities 1, 2, and 3 in bulk and formulations. The separation was achieved on Phenomenex column with Luna C18 (250 mm × 4.6 mm, 5 μm) as stationary phase, and 50 mM ammonium acetate: methanol solution 15:80 (v/v) at pH 5.2 as mobile phase at 1.0 mL/min flow rate. UV detection was carried at wavelength of 239 nm. In these conditions the retention time of darolutamide and its impurities 1, 2, and 3 was 7.05, 8.90, 4.63 and 5.95 min, respectively. The method was validated for system suitability, range of analysis, precision, specificity, stability, and robustness. Forced degradation study was done through exposure of the analyte to five different stress conditions and the % degradation was small in all degradation condition. The proposed method can separate and estimate the drug and its impurities in pharmaceutical formulations. Hence, the developed method was suitable for the quantification of darolutamide and can separate and analyse impurities 1, 2, and 3

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Section: Preparation Of Solutions: Darolutamide and Impurity Solutionsmentioning

confidence: 99%

Development and validation of a novel stability indicating HPLC method for the separation and determination of darolutamide and its impurities in pharmaceutical formulations

Kamani¹,

Sujatha²,

Daddala³

2021

Bull. of the Kar. Univ. "Chem". Ser.

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Analysis of Aspirin, Prasugrel and Clopidogrel in Counterfeit Pharmaceutical and Herbal Products: Plackett–Burman Screening and Box–Behnken Optimization

Mohammad

Elkady

Fouad

et al. 2020

Journal of Chromatographic Science

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An isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for the simultaneous determination of aspirin, prasugrel HCl and clopidogrel bisulfate in the presence of clopidogrel-related compound (impurity-A) in focus on counterfeit. This method was used to determine counterfeited antiplatelet drugs in two substandard Indian pharmaceutical products sold on the market in Yemen and two traditional herbal medicines sold on the market in China. Thin layer chromatography and mass spectrometry of counterfeit herbal medicines have additionally been carried out to verify the identification of adulterants. Chromatographic separation was performed on Inertsil ® ODS-3 C18 (4.6 × 250 mm, 5 μm) with isocratic mobile phase elution containing a mixture of acetonitrile: (25 mM) potassium dihydrogen phosphate buffer, pH 2.7 adjusted with 0.1 M o-phosphoric acid (79: 21, v/v), at a flow rate of 1 mL/min and UV detection at 220 nm. Designs of experiment methodology, Plackett–Burman and Box–Behnken designs were used for the screening and optimization of the mobile phase composition. The method validation was also performed in accordance with the International Council on Harmonization (ICH) guidelines. The method developed for routine analysis was found to be sensitive, simple, accurate and highly robust. The results were statistically compared to reference methods using Student’s t-test and variance ratio F-test at P < 0.05.

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HPLC Method for Determination of Aspirin, Rosuvastatin, Ezetimibe and Clopidogrel in Combination Drug Products

Cited by 2 publications

References 15 publications

Development and validation of a novel stability indicating HPLC method for the separation and determination of darolutamide and its impurities in pharmaceutical formulations

Development and validation of a novel stability indicating HPLC method for the separation and determination of darolutamide and its impurities in pharmaceutical formulations

Analysis of Aspirin, Prasugrel and Clopidogrel in Counterfeit Pharmaceutical and Herbal Products: Plackett–Burman Screening and Box–Behnken Optimization

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