RP-UFLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CLOPIDOGREL, PANTOPRAZOLE AND ROSUVASTATIN IN HUMAN PLASMA: DRUG INTERACTION STUDIES
Objectives: Objective of our present study was to develop a novel ultra fast liquid chromatographic method for quantitative simultaneous estimation of Clopidogrel, Pantoprazole & Rosuvastatin in human plasma and to validate the developed method following USFDA guidelines.
Methods: In the current study, the analysis was performed on phenomenex C8 (250 Ã— 4.6 mm, 5Î¼m) column using phosphate buffer (pH-2.5) and acetonitrile (45: 55 v/v) as mobile phase at flow rate of 1.2 mL/min. The system consisted of a pump (Shimadzu, prominence, UFLC), with 20 Âµl sample injector, along with a PDA detector at a wavelength of 254, 243 nm and 220 nmÂ for Clopidogrel, Pantoprazole and Rosuvastatin respectively. Data was compiled using Shimadzu LC Solution software.
Results: In this developed method Clopidogrel, Pantoprazole & Rosuvastatin, eluted at a retention time of 2.566, 5.002 and 9.301 min respectively. The proposed method is having linearity in the concentration range from 5 to 50Î¼g/mL of Clopidogrel, Pantoprazole & Rosuvastatin. The current method was validated with respect to accuracy, linearity; precision, lowest limit of quantification (LLOQ) and recovery according to the USFDA guidelines. Â A good linear relationship over the concentration range of 5-50Âµg/ml was shown. Validation of the method was carried out as per the USFDA draft guidelines.
Conclusion: A novel specific, accurate, precise UFLC method was developed for quantitative simultaneous estimation of Clopidogrel, Pantoprazole & Rosuvastatin in human plasma and validated. The developed method is suitable and economic for routine analysis and pharmacokinetic studies of Clopidogrel, Pantoprazole & Rosuvastatin simultaneously. The method developed was found to be precise, accurate, specific, linear and sensitive. Statistical analysis shows that the method is reproducible and selective for the estimation of Clopidogrel, Pantoprazole & Rosuvastatin in dosage form of patient plasma.
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