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PHARMASPIRE - Volume 12, Issue 1, January-March, 2020

Pages: 28-31

Date of Publication: 14-Jun-2022

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Development of single in vitro dissolution method for fixed-dose combination of atorvastatin and aspirin

Author: Navjot K Sandhu, Pooja Chawla

Category: Pharmaceutics


Introduction: This investigation aimed to develop and validate a dissolution method for a combination of atorvastatin and aspirin tablets using the ultraviolet (UV) spectrophotometric method. The analytical method was developed by UV spectrophotometry using the absorbance ratio method which involves the measurement of absorbance at two wavelengths 246 nm as the λmax of atorvastatin and 212 nm for aspirin as isoabsorbtive point. The method was validated according to ICH guidelines which include accuracy, precision, specificity, linearity, and analytical range. Furthermore, the stability and solubility of both the drugs in different media, that is, water and phosphate buffer of different pH were studied. Procedure: Based on this, the established dissolution conditions were 900 mL of 0.2 M phosphate buffer pH 6.8 as dissolution medium at 37±0.5°C, using USP apparatus II at a stirring rate of 75 rpm for 1 h. The corresponding dissolution profiles were constructed, and all the selected brands showed more than 80% drug release within 45 min. Results:Thus, the proposed dissolution method and analytical method can be applied successfully for the quality control of atorvastatin and aspirin in marketed tablets.

Keywords: Dissolution, atorvastatin, ICH guidelines, aspirin, ultraviolet spectrophotometric method


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