Quantitative analysis of sodium picosulfate in the presence of its alkaline degradation product

Ivana Savić, Goran Nikolić, Ivan Savić

Abstract


A new procedure for the analytical control of a pharmaceutical formulation by high performance liquid chromatographic (HPLC) is proposed. It allows the simultaneous determination of the major compounds in the formulation of the active compound (sodium picosulfate) and the degradation product (impurity), which slowly degrades by hydrolysis with different concentrations of sodium hydroxide, at different temperatures. Separation of sodium picosulfate from the degradation product was performed using the ZORBAX Eclipse XDB C-18 column, with a mobile phase consisting of phosphate buffer (pH = 7) : acetonitrile 85:15 v/v. The method was validated using the HPLC procedure, evaluating selectivity, accuracy, linearity and precision. The proposed method was successfully applied, with excellent recovery, to the analysis of a pharmaceutical formulation (Sodium picosulfate, Zdravlje-Actavis, Serbia) containing sodium picosulfate.

Keywords


sodium picosulfate; alkaline degradation; HPLC; kinetics

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References


European Pharmacopoeia, Directorate for the Quality of Medicines of the Council of Europe, Strasbourg, France, Fourth ed., Supplement 4.6, Monograph 01/2004:0929.

United States Pharmacopoeia, 27th ed., Rockville, MD, USA, 2003, p. 1102.

J. Morton, The detection of laxative abuse, Ann Clin Boichem, 24 (1), 107–108 (1987).

R. Kok, D. Faber, Qualitative and quantitative analysis of some synthetic chemically acting laxatives in urine by gas-chromatography-mass spectrometry, J. Chromatogr., 222, 389–398 (1981).

R. Fullinfaw, R. Bury, R. Moulds, Screening procedure for stimulant laxatives in urine using high-performance liquid chromatography with diode array detection, J. Chromatogr., 433, 131–140 (1988).

C. Pijnenburg, A. Duchateau, J. Conemans, F. Gerkens, R. Snoeren, C. Barella, Systematische toxicologische analyse van geneesmiddelen met behulp van HPLC en UV-detectie, Ziekenhuisfarmacie, 6 (1), 1–4 (1990).

R. Jauch, R. Hankwity, K. Beschke, H. Pelzer, Bis-(phydroxyphenyl)-pyridyl-2-methane: the common laxative principle of bisacodyl and sodium picosulfate, Arzneim Forsch, 25 (11), 1796–1800 (1975).

L. Stolk, K. Hoogtanders, Detection of laxative abuse by urine analysis with HPLC and diode array detection, Pharm. World Sci., 21 (1), 40–43 (1999).

M. Blanco, J. Coello, H. Iturriaga, S. Maspoch, C. Meseda Perez, Use of inverse multiple linear regression (ILS) for the analytical control of pharmaceutical preparations. UV-visible spectrophotometric quantitation of an active principal in the presence of absorbing excipients, J. Chromatogr. A, 799, 301 (1998).

K. Altria, M. Kelly, B. Clark, Current applications in the analysis of pharmaceuticals by capillary electrophoresis, Trends Anal. Chem., 17, 214–226 (1998).

M. Blanco, J. Coello, H. Iturriaga, S. Maspoch, M. Romero, Analytical control of a pharmaceutical formulation of sodium picosulfate by caillary zone electrophoresis, J. Chromatogr. B, 751, 29–36 (2001).

The European Agency for the Evaluation of Medicinal Products. ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95, 1996.

Jugoslovenska farmakopeja, V ed., Beograd, Savremena administracija, 2000.

S. Bolton, Pharmaceutical Statistics: practical and clinical application, III ed., Marcel Dekker, New York, 1997, pp. 216.

Ph. Hubert, J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, STP Pharma Pratiques, 13

(3), 101 (2003).

E. Chapuzet, N. Mercier, S. Bervoas-Martin, B. Boulanger, P. Chevalier, P. Chiap, D. Grandjean, Ph. Hubert, P. Lagorce, M. Lallier, M. Laparra, M. Laurentie, J. Nivet, STP Pharma Pratiques, 7, 169 (1997).

Ph. Hubert, P. Chiap, J. Crommen, B. Boulanger, E. Chapuzet, N. Mercier, B. Bervoas-Martin, P. Chevalier, D. Grandjean, P. Lagorce, M. Lallier, M. Laparra, M. Laurentie, J. Nivet, The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the Laboratory, Anal. Chem. Acta, 391, 135–148 (1999).

ISO 5725-1, Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement. Part 1: General principles and definitions, International Organization for Standardization (ISO), Geneva, Switzerland.

J. Ermer, Validation in pharmaceutical analysis, J. Pharm. Biomed. Anal, 24, 755–769 (2001).

D. Perez-Bendito, M. Silva, Kinetic Methods in Analytical Chemistry, Ellis Hor wood, Chichester, 1988, pp. 254.

H. Mottola, Kinetic Aspects of Analytical Chemisry, Wiley, New York, 1988, pp. 40.

V. Thomsen, D. Schatzlein, D. Mercuro, Spectroscopy, 18, 112 (2003).

C. Hartmann, J. Smeyers-Verbeke, W. Penninckx, Y. Heyden, P. Vankeerberghen, D. Massart, Anal. Chem. 67, 4491 (1995).

D. Skoog, D. West, F. Holler, Fundamentals of Analytical Chemistry, Saunders College Publishing, Philadelpia, 1996, pp. 51.

A. Florence, D. Attwood, Physical Principles of Pharmacy, II ed., Macmillan Press, 1998.




DOI: http://dx.doi.org/10.20450/mjcce.2009.204

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