High-performance liquid chromatography and derivative spectrophotometry for simultaneous determination of pravastatin and fenofibrate in the dosage form

Open access

Abstract

High performance liquid chromatography (HPLC) and second-order derivative spectrophotometry have been used for simultaneous determination of pravastatin (PS) and fenofibrate (FF) in pharmaceutical formulations. HPLC separation was performed on a phenyl HYPERSIL C18 column (125 mm × 4.6 mm i.d., 5 μm particle diameter) in the isocratic mode using a mobile phase acetonitrile/0.1 % diethyl amine (50:50, V/V, pH 4.5) pumped at a flow rate of 1.0 mL min-1. Measurement was made at 240 nm. Both drugs were well resolved on the stationary phase, with retention times of 2.15 and 5.79 min for PS and FF, respectively. Calibration curves were linear (R = 0.999 for PS and 0.996 for FF) in the concentration range of 5-50 and 20-200 µg mL-1 for PS and FF, respectively. Pravastatin and fenofibrate were quantitated in combined preparations also using the second-order derivative response at 237.6 and 295.1 nm for PS and FF, respectively. Calibration curves were linear, with the correlation coefficient R = 0.999 for pravastatin and fenofibrate, in the concentration range of 5-20 and 3-20 µg mL-1 for PS and FF, respectively. Both methods were fully validated and compared, the results confirmed that they were highly suitable for their intended purpose.

1. A. A. Al-Badr and G. A. E. Mostafa, Pravastatin sodium, Comprehensive Profile, Prof. Drug Subst. Exc. Rel. Meth. 39 (2014) 433-513.

2. M. Farnier, Pravastatin and fenofibrate in combination (Pravafenix®) for the treatment of high-risk patients with mixed hyperlipidemia, Expert Rev. Cardiovasc. Ther. 11 (2013) 253-254; DOI: 10.1586/ erc.12.191.

3. S. Bauer, J. Mwinyi, A. Stoeckle, T. Gerloff and I. Roots, Quantification of pravastatin in human plasma and urine after solid phase extraction using high performance liquid chromatography with ultraviolet detection, J. Chromatogr. B 818 (2005) 257-262; DOI: 10.1016/j.jchromb.2005.01.006.

4. T. D. Silva, M. A. Oliveira, R. B. de Oliveira and C. D. Vianna-Soares, Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin, J. Chromatogr. Sci. 50 (2012) 831-838; DOI: 10.1093/chromsci/bms079.

5. R. Siekmeier, W. Gross and W. März, Determination of pravastatin by high performance liquid chromatography, Int. J. Clin. Pharmacol. Ther. 38 (2000) 419-425.

6. H. Vlčková, M. Rabatinová, A. Mikšová, G. Kolouchová, S. Mičuda, P. Solich and L. Nováková, Determination of pravastatin and pravastatin lactone in rat plasma and urine using UHPLC-MS/ MS and microextraction by packed sorbent, Talanta 90 (2012) 22-29; DOI: 10.1016/j.talanta.2011.12.043.

7. Z. Zhu and L. Neirinck, High-performance liquid chromatography coupled with negative ion tandem mass spectrometry for determination of pravastatin in human plasma, J. Chromatogr. B 783 (2003) 133-140; DOI: 10.1016/S1570-0232(02)00526-3.

8. D. Mulvana, M. Jemal and S. C. Pulver, Quantitative determination of pravastatin and its biotransformation products in human serum by turbo ion spray LC/MS/MS, J. Pharm. Biomed. Anal. 23 (2000) 851-866, DOI: 10.1016/S0731-7085(00)00372-1.

9. K. Kawabata, N. Matsushima and K. Sasahara, An automated method for the simultaneous determination of pravastatin and its main metabolite in human plasma by high-performance liquid chromatography/atmospheric pressure chemical ionization mass spectrometry, Biomed. Chromatogr. 12 (1998) 271-275; DOI: 10.1002/(SICI)1099-0801(199809/10)12:5 < 27.

10. B. Nigović, Electrochemical properties and square-wave voltammetric determination of pravastatin, Anal. Bioanal. Chem. 384 (2006) 431-437.

11. United States Pharmacopoeia 30, USP Convention Inc., Rockville, 2007.

12. British Pharmacopoeia 2004, The Stationary Office, London 2004, p. 639.

13. R. J. Straka, R. T. Burkhardt and J. E. Fisher, Determination of fenofibric acid concentrations by HPLC after anion exchange solid-phase extraction from human serum, Ther. Drug Monit. 29 (2007) 197-202; DO I: 10.1097/ftd.0b013e318030860a.

14. A. A. Kadav and D. N. Vora, Stability indicating UPLC method for simultaneous determination of atorvastatin, fenofibrate and their degradation products in tablets, J. Pharm. Biomed. Anal. 48 (2008) 120-126; DOI: 10.1016/j.jpba.2008.05.018.

15. D. Bhavesh, S. Shah and Shivprakash, Determination of fenofibric acid in human plasma by ultra performance liquid chromatography-electrospray ionization mass spectrometry: application to a bioequivalence study, Biomed. Chromatogr. 23 (2009) 922-928, DOI: 10.1002/bmc.1203.

16. C. Yardimci and N. Ozaltin, Electrochemical studies and square-wave voltammetric determination of fenofibrate in pharmaceutical formulations, Anal. Bioanal. Chem. 378 (2004) 495-498; DOI: 10.1007/s00216-003-2246-x.

17. M. A. Korany, I. I. Hewala and K. M. Abdel-Hay, Determination of etofibrate, fenofibrate, and atorvastatin in pharmaceutical preparations and plasma using differential pulse polarographic and square wave voltammetric techniques, J AOAC Int. 91 (2008) 1051-1058.

18. P. D. Anumolu, N. S. Bhavani, P. S. Babu and C. Sburahmanyam, A validated spectral discriminating derivative spectrophotometric method for simultaneous quantification of atorvastatin calcium and fenofibrate combination in tablets, Orint. J. Chem. 29 (2013) 1605-1610, DOI: 10.13005/ ojc/290444.

19. A. Patel, C. Macwana, V. Pamar and S. Patel, Simultaneous determination of atorvastatin calcium, ezetimibe, and fenofibrate in tablet formulation by HPLC, JAOAC 95 (2012) 419-423.

20. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1), ICH Complementary Guideline on Methodology dated 06 November 1996, incorporated in November 2005, London.

21. FDA Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER ), Center for Biologics Evaluation and Research (CBER), Rockville (MD) 2001.

22. J. N. Miller and J. C. Miller, Statistics and Chemometrics for Analytical Chemistry, 2nd ed., Pearson Education Limited, Harlow 2005.

Acta Pharmaceutica

The Journal of Croatian Pharmaceutical Society

Journal Information


IMPACT FACTOR 2017: 1.071
5-year IMPACT FACTOR: 1.623

CiteScore 2017: 1.46

SCImago Journal Rank (SJR) 2017: 0.362
Source Normalized Impact per Paper (SNIP) 2017: 0.642

Metrics

All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 264 264 33
PDF Downloads 86 86 7