Development and validation of a stability-indicating method for determination of ropinirole in the bulk drug and in pharmaceutical dosage forms

• Autorzy: Azeem A. , Iqbal Z. , Ahmad F. J. , Khar R. K. , Talegaonkar S.
• Języki publikacji: PL

Abstrakty

EN

An accurate, sensitive, precise, rapid, and isocratic reversed phase HPLC (RP-HPLC) method for analysis of ropinirole in the bulk drug and in pharmaceutical preparations has been developed and validated. The best separation was achieved on a 250 mm × 4.6 mm i.d, 5-µm particle, C₁₈ reversed-phase column with methanol-0.05 M ammonium acetate buffer (pH 7) 80:20 (v/v) as mobile phase, at a flow rate of 1 mL min^-1. UV detection was performed at 250 nm. The method was linear over the concentration range 0.2-100 µg mL^-1 (r = 0.9998), with limits of detection and quantitation of 0.061 and 0.184 µg mL^-1, respectively. The drug was subjected to oxidation, hydrolysis, photolysis, and heat as stress conditions. Degradation products resulting from the stress did not interfere with detection and assay of ropinirole and thus the method can be regarded as stability-indicating. The method can be used for quality-control assay of ropinirole.

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2008
• Tom: Vol. 20, no. 1
• Strony: 95--107
• Opis fizyczny: Bibliogr. 20 poz., rys., tab.

Twórcy

autor

Azeem A.

autor

Iqbal Z.

autor

Ahmad F. J.

autor

Khar R. K.

autor

Talegaonkar S.

• Jamia Hamdard Department of Pharmaceutics, Faculty of Pharmacy New Delhi 110062 India

Bibliografia

• [1] D. Nyholm, Clin. Pharmacokinet., 45, 109 (2006)
• [2] C.M. Kaye and B. Nicholls, Clin. Pharmacokinet., 39, 243 (2000)
• [3] D.G. Standaert and A.B. Young, in L.L. Bruton, J.S. Lazo, and K.L. Parker (Eds) Goodman Gilman’s The Pharmacological Basis of Therapeutics, 11th edn, International Edition, McGraw–Hill, 2006, pp. 527–538
• [4] A.J. Matheson and C.M. Spencer, Drugs, 60, 115 (2000)
• [5] J.V. Ramji, I.P. Keogh, T.J. Blake, C. Broom, R.J. Chenery, D.R. Citerone, V.A. Lewis, A.C. Taylor, and S.E. Yeulet, Xenobiotica, 29, 311 (1999)
• [6] J.E. Swagzdis and B.A. Mico, J. Pharm. Sci., 75, 90 (1986)
• [7] J.E. Swagzdis, R. Gifford, and B.A. Mico, J. Chromatogr., 345, 203 (1985)
• [8] J. Bhatt, A. Jangid, R. Shetty, B. Shah, S. Kambli, G. Subbaiah, and S. Singh, J. Pharm. Biomed. Anal., 43, 1202 (2006)
• [9] I.G. Beattie and T.J.A. Blake, J. Chromatogr., 474, 123 (1989)
• [10] P. Coufal, K. Stulik, H.A. Claeessens, M.J. Hardy, and M. Webb, J. Chromatogr. B, 732, 437 (1999)
• [11] B. Saharabuddhey, R. Nautiyal, H. Acharya, S. Khyade, P.K. Luthra, P.B. Deshpande, J. Pharm. Biomed. Anal., 43, 1587 (2007)
• [12] K.D. Zissis, R.G. Brereton, and R. Escott, Analyst 122, 1007 (1997)
• [13] A. Onal, Chromatographia, 64, 459 (2006)
• [14] A. Onal and S. Caglar, Chem. Pharm. Bull., 55, 629 (2007)
• [15] FDA, Guidance for Industry: Impurities in Drug Product, Draft Guidance, Center for Drug Evaluation and Research (CDER), 1998
• [16] International Conference on Harmonization (ICH), Guidance for Industry, Q1A (R2): Stability Testing of New Drug Substances and Products, IFPMA, Geneva, 2003
• [17] W. Grimm, in J.T. Cartensen and C.T. Rhodes (Eds) Drug Stability, Principles and Practices, Marcel Dekker, New York, 2000
• [18] International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), November 2005
• [19] M. Zeaiter, J.M. Roger, V.B. Maurel, and D.N. Rutledge, Trends Anal. Chem., 23, 157 (2004)
• [20] M. Mulholland, Trends Anal. Chem., 7, 383 (1988).