DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ASPIRIN, ATORVASTATIN CALCIUM AND CLOPIDOGREL BISULPHATE IN BULK DRUGS FORMULATION

*Abhinandan A. Alman, Mohan D. Dhere and Suresh G. Killedar

ABSTRACT

Introduction: A rapid, accurate, simple andeconomical reverse phase high performance liquid chromatographic method was developed for simultaneous estimation of Aspirin (ASP), Atorvastatin Calcium (ATO) and Clopidogrel Bisulphate (CLO) in bulk drug and pharmaceutical dosage form. Materials and Methods: This precise and specific method was operated by adopting the mobile phase containingAcetonitrile: phosphate buffer in ratio 50:50, v/v pH 3.0 which has been adjusted with o-phosphoric acid and found to be most suitable for RP-HPLC. The current Separation has been performed on Inertsil ODS-RP-18 column (150 mm x 46 mm) in isocratic mode along with flow rate of 1.2 ml/min and effluents were monitored at 235 nm. Results: It shows sharp peak with effective retention time like 1.89 min. (ASP), 6.6 min. (ATO) and 19.8 min. (CLO) respectively. The linearity for ASP, ATO and CLO shows in the range of 30-105 μg/ml, 5-30 μg/ml and 30-105 μg/ml respectively. Recovery results of ASP, ATO and CLO has been found in between of 98.81-100.35 %, 98.28-100.70 % and 99.41-100.61 % respectively. Conclusion: This proposed method validation was performed using parameters like accuracy, precision, specificity, linearity, ruggedness and robustness. Current developed PR-HPLC method will be applicable for the simultaneous estimation of these drugs in different pharmaceutical dosage forms due to its specificity and high precision.

Keywords: RP-HPLC, Validation, Aspirin, Clopidogrel Bisulphate, Atorvastatin Calcium.