DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN, ROSUVASTATIN, CLOPIDOGREL IN BULK AND PHARMACEUTICAL DOSAGE FORM
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2018, Vol 10, Issue 10
Abstract
Objective: To develop a novel, accurate, precise and linear reverse phase high-performance liquid chromatography (RP-HPLC) and Stability Indicating Assay Method (SIAMs) for simultaneous, qualitative and quantitative estimation of aspirin, rosuvastatin and clopidogrel in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines.Method: In the present work, good chromatographic separation was achieved by isocratic method using a BISCOF HPLC C18 column (250 mm ×4.6, 5 µm) and a mobile phase consisting of water at pH 2.51 with 0.1 % (v/v) orthophosphoric acid (OPA): acetonitrile in the ratio 50:50, at a flow rate of 1 ml/min. The effluents obtained were monitored at 237 nm with the UV-visible detector.Results: The retention time of aspirin, rosuvastatin, and clopidogrel was found to be 4.3 min, 7.6 min and 16.6 min respectively. For linearity seven-point calibration curves were obtained in a concentration range from 1-7 µg/ml for aspirin, rosuvastatin and clopidogrel with correlation coefficient 0.999, 0.9989, 0.9988 respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise. In the present study stability indicating an RP-HPLC method for the combination was tested by degrading the drugs together under various stress condition like acid, base and neutral hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH.Conclusion: The developed RP-HPLC method is simple, economic, specific, accurate and precise for the simultaneous estimation of aspirin, rosuvastatin, and clopidogrel in the combined capsule dosage form. The developed stability indicating analytical method can be used to check the stability of the compounds and was found suitable to determine % degradation of drugs in pharmaceutical dosage form.
Authors and Affiliations
Pooja Pisal, Ganesh Nigade, Amol Kale, Smita Pawar
Keywords
Related Articles
- EP ID EP566126
- DOI 10.22159/ijpps.2018v10i10.28329
- Views 95
- Downloads 0
SPECTROPHOTOMETRIC DETERMINATION OF PROPRANOLOL HYDROCHLORIDE AND METOPROLOL TARTRATE IN PHARMACEUTICAL DOSAGE FORMS, SPIKED WATER AND BIOLOGICAL FLUIDS
Objective: A new spectrophotometric method for the determination of propranolol hydrochloride (PRO) and metoprolol tartrate (MTP), beta blocker drugs, has been developed for their analysis in pharmaceutical dosage forms...
DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF CURCUMIN, PIPERINE AND CAMPHOR IN AN AYURVEDIC FORMULATION
Objective: To develop a novel, accurate, precise and linear reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous qualitative and quantitative estimation of curcumin, piperine and campho...
ULTRAFILTRATED FRACTION OF KOREAN RED GINSENG EXTRACT IMPROVES MEMORY IMPAIRMENT OF TG2576 MICE VIA INHIBITION OF SOLUBLE AÎ’ PRODUCTION AND ACETYLCHOLINESTERASE ACTIVITY
Objective: The goal of this study was to research for an effective fraction on memory improvement of Korean red ginseng.Methods: In this study, 80 % ethanol red ginseng extract (RE) was divided into inner fluid (REUI) an...
CHITOSAN MUCOADHESIVE BUCCAL FILMS: EFFECT OF DIFFERENT CASTING SOLVENTS ON THEIR PHYSICOCHEMICAL PROPERTIES
Objective: The aim of this work is to investigate the influence of different casting solvents on the physicochemical properties of cetylpyridinium chloride (CPC) chitosan mucoadhesive buccal films.Methods: Screening form...
ASSAY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF DILOXANIDE FUROATE AND TINIDAZOLE IN TABLETS BY RP-HPLC
Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for simultaneous quantitative estimation of Diloxanide furoate and Tinidazole in tablets and va...