SIMULTANEOUS DETERMINATION OF ATORVASTATIN AND ATENOLOL IN RABBIT PLASMA BY RP-HPLC METHOD AND ITS APPLICATION IN PHARMACOKINETIC STUDY

SURAJ KUMAR SHAH; SANJAY DEY; SOURAV DE

doi:10.22159/ijcpr.2022v14i2.1968

Authors

SURAJ KUMAR SHAH Department of Pharmaceutical Technology, School of Medical Science, Adamas University, Kolkata 700126, West Bengal, India
SANJAY DEY Department of Pharmaceutical Technology, School of Medical Science, Adamas University, Kolkata 700126, West Bengal, India
SOURAV DE Department of Pharmaceutical Technology, School of Medical Science, Adamas University, Kolkata 700126, West Bengal, India

DOI:

https://doi.org/10.22159/ijcpr.2022v14i2.1968

Keywords:

Atorvastatin, Atenolol, RP-HPLC, Pharmacokinetic study, Rabbit, Bilayer tablet

Abstract

Objective: The objective of the present study is to establish a simple, sensitive, and specific RP-HPLC technique to determine atorvastatin calcium (ATV) and atenolol (ATL) in rabbit plasma.

Methods: Both the drugs like atorvastatin calcium and atenolol have been extracted by simple liquid-liquid extraction with acetonitrile.

Results: The chromatographic separation has performed on a reversed-phase C₁₈ column with a mobile phase of phosphate buffer (pH 4.0): acetonitrile: methanol (40:40:20, v/v). The techniques have been validated over the concentration range of 22.08-4778.37 ng ml^-1 for ATV and 18.35-3969.20 ng ml^-1 for ATL in rabbit plasma. The acceptability range was satisfied for all validation criteria. These methods have been profitably applied to the pharmacokinetic study of a bilayer tablet of ATV and ATL after an oral administration to a rabbit. A significant recovery of the drug from plasma resulted from acetonitrile as extracting solvent compared to other organic solvents.

Conclusion: The results obtained proved that the RP-HPLC method developed was accurate and reproducible, and the drug was stable in rabbit plasma.

Downloads

Download data is not yet available.

References

O’Neil MJ. The merck index. 14th ed. Whitehouse Station, NJ: Merck Research Laboratories; 2006. p. 864-6.

Beringer P. Remingtons–the science and practice of pharmacy. 21st ed. Vol. II. Easton, PA: Mack Publishing; 2005. p. 1368-70.

Manoj K, Shanmugapandiyan P, Anbazhagan S. RP-HPLC method for simultaneous estimation of atorvastatin calcium and aspirin from capsule formulation. Indian Drugs. 2004;41:284-9.

Erturk S, Sevinc Aktas E, Ersoy L, Ficicioglu S. An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets. J Pharm Biomed Anal. 2003;33(5):1017-23. doi: 10.1016/s0731-7085(03)00408-4. PMID 14656592.

Yadav SS, Mhaske DV, Kakad AB, Patil BD, Kadam SS, Dhaneshwar SR. A simple and sensitive HPTLC method for the determination of content uniformity of atorvastatin calcium tablets. Indian J Pharm Sci. 2005;67:182-5.

Delamoye M, Duverneuil C, Paraire F, de Mazancourt P, Alvarez JC. Simultaneous determination of thirteen beta-blockers and one metabolite by gradient high-performance liquid chromatography with photodiode-array UV detection. Forensic Sci Int. 2004;141(1):23-31. doi: 10.1016/ j.forsciint.2003.12.008. PMID 15066710.

Yamamoto E, Sakaguchi T, Kajima T, Mano N, Asakawa N. Novel methylcellulose-immobilized cation-exchange precolumn for on-line enrichment of cationic drugs in plasma. J Chromatogr B. 2004;807(2):327-34. doi: 10.1016/j.jchromb.2004.04.028.

Dobson CL, Davis SS, Chauhan S, Sparrow RA, Wilding IR. The effect of ileal brake activators on the oral bioavailability of atenolol in man. Int J Pharm. 2002;248(1-2):61-70. doi: 10.1016/s0378-5173(02)00393-9, PMID 12429460.

Park YJ, Lee DW, Lee WY. Determination of β-blockers in pharmaceutical preparations and human urine by high-performance liquid chromatography with tris(2,2′-bipyridyl)ruthenium(II) electrogenerated chemiluminescence detection. Anal Chim Acta. 2002;471(1):51-9. doi: 10.1016/S0003-2670(02)00932-7.

Ranta VP, Toropainen E, Talvitie A, Auriola S, Urtti A. Simultaneous determination of eight β-blockers by gradient high-performance liquid chromatography with combined ultraviolet and fluorescence detection in corneal permeability studies in vitro. J Chromatogr B. 2002;772(1):81-7. doi: 10.1016/S1570-0232(02)00059-4.

Mislanova C, Hutta M. Influence of various biological matrices (plasma, blood microdialysate) on chromatographic performance in the determination of beta-blockers using an alkyl-diol silica precolumn for sample clean-up. J Chromatogr B Biomed Sci Appl. 2001;765(2):167-77. doi: 10.1016/s0378-4347(01)00423-6, PMID 11767310.

Li X, Yao T, Zeng S. Reversed-phase high-performance liquid chromatographic analysis of atenolol enantiomers in rat hepatic microsome after chiral derivatization with 2,3,4,6-tetra-O-acetyl-β-d-glycopyranosyl isothiocyanate. J Chromatogr B. 2000;742(2):433-9. doi: 10.1016/S0378-4347(00)00178-X.

Chiap P, Buraglia BM, Ceccato A, Hubert P, Crommen J. Automated liquid chromatographic determination of atenolol in plasma using dialysis and trace enrichment on a cation-exchange precolumn for sample handling. J Chromatogr B Biomed Sci Appl. 2000;739(1):205-17. doi: 10.1016/s0378-4347(99)00518-6. PMID 10744328.

Saha P, Kim KJ, Yamahara H, Crandall ED, Lee VHL. Influence of lipophilicity on β-blocker permeation across rat alveolar epithelial cell monolayers. J Control Release. 1994;32(2):191-200. doi: 10.1016/0168-3659(94)90057-4.

Augustijns P, Mols R. HPLC with programmed wavelength fluorescence detection for the simultaneous determination of marker compounds of integrity and P-gp functionality in the Caco-2 intestinal absorption model. J Pharm Biomed Anal. 2004;34(5):971-8. doi: 10.1016/j.jpba.2003.11.016, PMID 15019031.

Lamprecht G, Kraushofer T, Stoschitzky K, Lindner W. Enantioselective analysis of (R)-and (S)-atenolol in urine samples by a high-performance liquid chromatography column-switching setup. J Chromatogr B Biomed Sci Appl. 2000;740(2):219-26. doi: 10.1016/s0378-4347(00)00080-3, PMID 10821408.

Miller RB. A validated high-performance liquid chromatographic method for the determination of atenolol in whole blood. J Pharm Biomed Anal. 1991;9(10-12):849-53. doi: 10.1016/0731-7085(91)80012-x, PMID 1822203.

Alebic Kolbah T, Plavsic F, Wolf Coporda A. Determination of serum atenolol using HPLC with fluorescence detection following isolation with activated charcoal. J Pharm Biomed Anal. 1989;7(12):1777-81. doi: 10.1016/0731-7085(89)80193-1, PMID 2490566.

Clark BJ, Fell AF, Jones DG. Digital techniques for luminescence detection in liquid chromatography with an intensified linear photodiode array. J Pharm Biomed Anal. 1988;6(6-8):843-52. doi: 10.1016/0731-7085(88)80100-6, PMID 16867352.

Castiglioni S, Bagnati R, Calamari D, Fanelli R, Zuccato E. A multi-residue analytical method using solid-phase extraction and high-pressure liquid chromatography-tandem mass spectrometry to measure pharmaceuticals of different therapeutic classes in urban wastewaters. J Chromatogr A. 2005;1092(2):206-15. doi: 10.1016/j.chroma.2005.07.012, PMID 16199227.

Hernando MD, Petrovic M, Fernandez-Alba AR, Barcelo D. Analysis by liquid chromatography-electrospray ionization tandem mass spectrometry and acute toxicity evaluation for β-blockers and lipid-regulating agents in wastewater samples. J Chromatogr A. 2004;1046(1-2):133-40. doi: 10.1016/S0021-9673(04)01070-2, PMID 15387181.

Abdel-Hamid ME. Comparative LC–MS and HPLC analyses of selected antiepileptics and beta-blocking drugs. Farmaco. 2000;55(2):136-45. doi: 10.1016/s0014-827x(00)00006-9, PMID 10782386.

Deveaux M, Kintz P, Goulle JP, Bessard J, Pepin G, Gosset D. The hair analysis proficiency testing program of the French Society of Analytical Toxicology. Forensic Sci Int. 2000;107(1-3):389-94. doi: 10.1016/s0379-0738(99)00181-4, PMID 10689589.

El-Gindy A, Emara S, Mostafa A. HPLC and chemometric-assisted spectrophotometric methods for simultaneous determination of atenolol, amiloride hydrochloride and chlorthalidone. Farmaco. 2005;60(3):269-78. doi: 10.1016/j.farmac.2004.11.013, PMID 15784248.

Patel YP, Patil S, Bhoir IC, Sundaresan M. Isocratic, simultaneous reversed-phase high-performance liquid chromatographic estimation of six drugs for combined hypertension therapy. Journal of Chromatography A. 1998;828(1-2):283-6. doi: 10.1016/s0021-9673(98)00652-9, PMID 9916313.

Giachetti C, Tenconi A, Canali S, Zanolo S, Zanolo G. G, Simultaneous determination of atenolol and chlorthalidone in plasma by high-performance liquid chromatography application to pharmacokinetic studies in man. Journal of Chromatography B. 1997;698(1-2):187-94. doi: 10.1016/S0378-4347(97)00298-3.

Modamio P, Lastra CF, Montejo O, Marifio EL. Development and validation of liquid chromatography methods for the quantitation of propranolol, metoprolol, atenolol and bisoprolol: application in solution stability studies. International Journal of Pharmaceutics. 1996;130(1):137-40. doi: 10.1016/0378-5173(95)04257-1.

Jain R, Jain CL. Simultaneous microquantification of nifedipine and atenolol in multicomponent dosage forms using high-performance liquid chromatography. Microchemical Journal. 1991;44(2):187-92. doi: 10.1016/0026-265X(91)90097-9.