Stability Indicating Simultaneous Validation of Aspirin, Clopidogrel and Rosuvastatin with Forced Degradation Behavior Study by RP-HPLC in Pharmaceutical Dosage Form
Journal Title: Asian Pacific Journal of Health Sciences - Year 2017, Vol 4, Issue 3
Abstract
For simultaneous validating anassay of Aspirin, Clopidogrel and Rosuvastatin in Capsule Dosage Form, a simple, precise and accurate RP-HPLC method has been developed. Isocratic RP-HPLC process was established on BDS hypersil C18 (250mm×4.6mm internal diameter, 5µ particle size) using mobile phase as 0.05M Potassium DihydrogenOrtho Phosphate (pH-4.0): Acetonitrile (60:40v/v) at a flow rate of 1.0 mL/min and at 235 nm the detection was carried out by using tunable absorbance detector (Waters 486). Forced degradation study was performed by acid, base and thermal degradation, as well as oxidation of the drug. The process was validated for accuracy, precision, linearity, and robustness. The method was found to be linear in the 15-45 𝜇g/mL of concentration range with 0.9988, 15-45 𝜇g/mL with 0.9983 and 2-6 𝜇g/mL with 0.9993 of correlation coefficient for Aspirin, Clopidogrel and Rosuastatin, respectively. Degradation products formedbecause of stress studies, did not interfere with the Aspirin, Clopidogrel and Rosuvastatin detection; consequently, the assay can be advised to be stability indicating.
Authors and Affiliations
Anurag Mishra
Keywords
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- EP ID EP525602
- DOI 10.21276/apjhs.2017.4.3.45
- Views 182
- Downloads 0
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