In Vitro Dissolution Study of Acetylsalicylic Acid and Clopidogrel Bisulfate Solid Dispersions: Validation of the RP-HPLC Method for Simultaneous Analysis
| Autor: | Maja Pašić-Kulenović, Ehlimana Osmanović Omerdić, Jadranka Odović, Larisa Alagić-Džambić, Dragana Vasiljević, Marko Krstić |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Solid dispersion
dissolution 010402 general chemistry lcsh:Technology 030226 pharmacology & pharmacy 01 natural sciences High-performance liquid chromatography lcsh:Chemistry 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Acetylsalicylic acid Validation medicine General Materials Science lcsh:QH301-705.5 Instrumentation Dissolution Fluid Flow and Transfer Processes Active ingredient Detection limit solid dispersion validation Chromatography Ethanol lcsh:T Chemistry Clopidogrel Bisulfate Process Chemistry and Technology General Engineering clopidogrel bisulfate Clopidogrel bisulfate acetylsalicylic acid lcsh:QC1-999 0104 chemical sciences 3. Good health Computer Science Applications Solvent lcsh:Biology (General) lcsh:QD1-999 lcsh:TA1-2040 RP-HPLC Poloxamer 407 lcsh:Engineering (General). Civil engineering (General) lcsh:Physics medicine.drug |
| Zdroj: | Applied Sciences Volume 10 Issue 14 Applied Sciences, Vol 10, Iss 4792, p 4792 (2020) Applied Sciences (Switzerland) |
| ISSN: | 2076-3417 |
| DOI: | 10.3390/app10144792 |
| Popis: | Solid dispersions were prepared via a solvent evaporation method, employing ethanol (96%, v/v) as solvent, with three different polymers as carrier: povidone, copovidone, and poloxamer 407. Previously developed reversed-phase HPLC (RP-HPLC) methods were modified and used for the simultaneous determination of acetylsalicylic acid and clopidogrel bisulfate and after release from solid dispersions. Chromatography was carried out on a C-18 column, with a mobile phase of acetonitrile&ndash methanol&ndash phosphate buffer pH 3.0, UV detection at 240 nm, and a run time of 6 min. The method was validated according to International Conference of Harmonisation guidelines and validation included specificity, accuracy, precision, linearity, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method is specific for determination of acetylsalicylic acid and clopidogrel bisulfate. The linearity was provided in the concentration range 0.0275&ndash 0.1375 mg/mL for acetylsalicylic acid and 0.0200&ndash 0.1000 mg/mL for clopidogrel bisulfate, with a correlation coefficient (R2 value) of 0.9999 for both active pharmaceutical ingredients (APIs). Accuracy was confirmed by calculated recoveries for acetylsalicylic acid (98.6&ndash 101.0%) and clopidogrel bisulfate (100.0&ndash 101.6%). The intra-day and the inter-day precision-calculated relative standard deviations are less than 1%, which indicates high precision of the method. The limits of detection and quantification for acetylsalicylic acid were 0.0004 and 0.0012 mg/mL, and for clopidogrel bisulfate 0.0002 mg/mL and 0.0007 mg/mL, respectively. Small variations in chromatographic conditions did not significantly affect qualitative and quantitative system responses, which proved robustness of method. The proposed RP-HPLC method was applied for simultaneous determination of clopidogrel bisulfate and acetylsalicylic acid from solid dispersions. |
| Databáze: | OpenAIRE |
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