DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN, ROSUVASTATIN, CLOPIDOGREL IN BULK AND PHARMACEUTICAL DOSAGE FORM

  • Pooja Pisal PDEA'S SGRS COLLEGE OF PHAMACY, SASWAD
  • Ganesh Nigade PDEA'S SGRS COLLEGE OF PHAMACY, SASWAD
  • Amol Kale PDEA'S SGRS COLLEGE OF PHAMACY, SASWAD
  • Smita Pawar PDEA'S SGRS COLLEGE OF PHAMACY, SASWAD

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.

Keywords: RP-HPLC, Stability indicating method, Aspirin, Rosuvastatin, Clopidogrel, ICH guideline

Downloads

Download data is not yet available.

References

1. Trialists Collaboration A. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high-risk patients. Br Med J 2002;324:71-6.
2. Boersma E, Harrington RA, Moliterno DJ, White H, Theroux P, Van de Werf Fand Simoons ML. Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials. Lancet 2002;359:189-98.
3. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. Clopidogrel in unstable angina to prevent recurrent events trial investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. New England J Med 2001;345:494-502.
4. Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK. Clopidogrel in unstable angina to prevent recurrent events trial (CURE) investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001;358:527-33.
5. Pursuit Trial Investigators, Inhibition of platelet glycoprotein Ib/IIIa with eptifibatide in patients with acute coronary syndromes. Platelet glycoprotein IIb/IIIa in unstable angina. Receptor suppression using integrilin therapy. New England J Med 1998;339:436-43.
6. PRISM Study Investigators. A comparison of aspirin plus tirofiban with aspirin plus heparin for unstable angina. New England J Med 1998;338:1498-505.
7. Singh RD, Yadav H, Hinge M, Patel A. Development and validation of analytical methods for simultaneous estimation of rosuvastatin, clopidogrel and aspirin in the pharmaceutical dosage form. J Pharm Sci Bioscientific Res 2016;6:197-205.
8. Badawey A, Mostafa N, Lamie N, El-Aleem A. Stability-indicating methods for the determination of rosuvastatin in the presence of its oxidative degradation products. Int J Pharm Res 2012;1:1-8.
9. Panchal A, Sanghvi G, Vachhani A, Seth N, Vaishnavi D. Simultaneous determination of aspirin and rosuvastatin calcium in capsules by using an RP-HPLC couple with photodiode array detection. Int Lett Chem Phys Astron 2014;33:218-30.
10. Gandhimathi M, Ravi TK. High performance liquid chromatographic determination of aspirin and clopidogrel in tablets. Indian J Pharm Sci 2007;69:123-5.
11. Nagavi JB, Gurupadayya B. Simultaneous estimation of clopidogrel and in human plasma using the bio-analytical RP-UPLC fast liquid chromatographic method. Int J Curr Pharm Res 2015;7:30-5.
12. Jain HK, Deore DD. Bioanalytical method development and validation for estimation of clopidogrel bisulphate in human plasma by RP-HPLC. Int J Appl Pharm 2016;4:18-21.
13. Sharma BK. Instrumental method of chemical analysis. 2nd ed. Goal publication House 1991;23:7-10.
14. Dong M. Regulatory aspects of HPLC analysis: HPLC system and method validation, modern HPLC for practicing scientists. John Wiley and Sons. New Jersey; 2006. p. 1.
15. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1); 2005.
16. FDA, Guidance R. Validation of chromatographic methods center for drug evaluation and research (CDER). Food Drug Administration; 1994. p. 2.
17. FDA. ORA validation and verification guidance for human drug analytical methods. Food Drug Administration; 2003. p. 1.
Statistics
206 Views | 793 Downloads
Citatons
How to Cite
Pisal, P., G. Nigade, A. Kale, and S. Pawar. “DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN, ROSUVASTATIN, CLOPIDOGREL IN BULK AND PHARMACEUTICAL DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 10, no. 10, Oct. 2018, pp. 50-56, doi:10.22159/ijpps.2018v10i10.28329.
Section
Original Article(s)