Manish BHATIA, Swapnil JADHAV, Santosh KUMBHAR

Gel permeation chromatographic method for drug protein binding studies

The estimation of individual plasma protein in free and bound form with analytes has importance in pharmacokinetics study. Albumins and globulins are most abundantly found in plasma and plays crucial role in plasma protein binding. The present communication deals with the development of gel permeation chromatographic method for the estimation of plasma protein binding studies for ketoprofen, tapentadol and furaltadone. The method was developed using WATER system with Ultrahydrogel column (7.8 x 300 mm i.d.), refractive index detector (1.00 to 1.75 RIU) and Rheodyne injection valve fitted with a 20µl sample loop using 0.1% sodium nitrate as a mobile phase. The method was developed by studying binding above drugs with most of plasma proteins. These complexes have shown linearity in range of 100 to 300µg/ml of these drugs. The developed method has been validated using USFDA guidelines. The developed bioanalytical method is accurate, precise, and selective and sensitive for quantification of plasma proteins bound drugs. The further optimization of method using other standard plasma proteins will explore its applicability in pharmacokinetic and biopharmaceutical studies of most of drugs.

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U.S. Department of Health and Human Services Food and Drug Administration (USFDA). Guidance for Industry: Bioanalytical Method Validation. Rockville: Center for Drug Evaluation and Research, USFDA, May 2001.

Pal PK, Ganesan M. Bioavailability and Bioequivalence in Pharmaceutical Technology, 1st ed. CBS Publishers and Distributors, New Delhi. 1999, pp 1–145.

Teresa F, Roman K, Michal M. Estimation of buspirone- Bovine serum albumin binding by affinity capillary electrophoresis. Acta Pol Pharm–Drug Res 2001; 58: 319-23.

Bardarov V, Shishenkov M, Bardarov K. Application of preparative size-exclusion chromatography (SEC) for separation/clean-up of platelets from blood plasma before their chemical investigation. J Univ Chem Technol Metallurgy 2012; 47: 97-102.

Alpert J, Shukla AK. Precipitation of large, high abundance proteins from serum with organic solvents. ABRF. 2003; (2/3; Denver): Poster# P111-W.

Jaldappa S, Bhalchandra K. Mechanism of interaction of vincristine sulphate and rifampicin with Bovine serum albumin: A spectroscopic study. J Chem Sci 2005; 117: 649– 55.

Jacinto S, Johanna K, Joan GL. Differences between bovine and human serum albumins. Binding isotherms, optical rotatory dispersion, viscosity, hydrogen ion titration, and fluorescence effects. Biochem 1971; 10: 4005–15.

Hiroyuki H, Motoaki A, Yasuyugi T. An endonuclease associated with bovine plasma albumin fraction’. J Biol Chem 1972; 247: 193-8.

Fernández SO, Rodríguez JA, Padilla AP. Removal concentration and desalination of bovine serum albumin (BSA) with membrane technology. European Conference on Desalination and the Environment 1999; 126: 95-100.

Winfried M, Rudiger S, Hubert S, Ullrich B, Werner G. Fast lipoprotein chromatography: New method of analysis for plasma lipoproteins. Clin Chem 1993; 39: 2276-81.

Van den Eijnden-van Raaij AJM, Koornneef I, van Oostwaard MJ, de Laat SW, van Zoelen EJJ. Cation-exchange highperformance liquid chromatography: separation of highly basic proteins using volatile acidic solvents. Anal Biochem 1987; 163: 263-9.

Shah RB, Yang Y, Khan MA, Faustino PJ. Molecular weight determination for colloidal iron by Taguchi optimized validated gel permeation chromatography. Int J Pharm 2008; 353: 21–7.

Kuzayev AI. Determining absolute molecular weights of styrene and ethylene oxide oligomers by gel permeation chromatography. Polymer Sci U.S.S.R. 1980; 22: 1260-7.

Plet JM, Van den O, Cees PM, Breed JS, Herman JH. Detection of serum proteins by high-pressure gel-permeation chromatography with low-angle laser light scattering compared with analytical ultracentrifugation. Clin Chem 1986; 32: 363-7.

Morris CJOR, Morris P. Molecular-Sieve chromatography and electrophoresis in polyacrylamide gels. Biochem J 1971; 124: 517-28.

Hideo H, Kayoko A, Ewamura J. Immunofluorescence determination of Ig G in cerebrospinal fluid following high performance liquid gel permeation chromatography. J Immunol Methods 1987; 98: 1-4.

David AH, Robert BF. Resolution of protein disulphideisomerase and glutathione-insulin transhydrogenase activities by covalent chromatography. Biochem J 1980; 191; 373-88.

Bernd T. Size-exclusion Chromatography of Polymers, Encyclopedia of Analytical Chemistry. Karl-FranzensUniversity, Graz, Austria. John Wiley & Sons Ltd. 2000, pp. 8008–8034.

Anastasios D. Applicability of the modified universal calibration of gel permeation chromatography on proteins. J Chromatogr 2006; 183–6.

Kratochwil NA, Walter H, Fransis M, Malfred K, Poul RJ. Predicting plasma protein binding of drugs: a new approach. Biochem Pharmacol 2002; 64: 1355-74.

Tajminr-Riahi HA. An overview of drug binding to human serum albumin: protein folding and unfolding. Scientia Iranica 2007; 14: 87-95.

Goodman GA. The pharmacological basis of therapeutics, 9th edition. MacGrow Hill, New York. 1996.