Chromatographic methods for determination of nimesulide and for stability studies

• Autorzy: Syed A. A. , Amshumali M. K. , Devan N.
• Języki publikacji: EN

Abstrakty

EN

Simple and rapid HPLC, GC, and TLC procedures have been developed for detection and determination of nimesulide, a non-pharmacopeial drug, in preformulation and dosage form. Use of these techniques has enabled separation of impurities and the precursor in the bulk material and in formulations. Isocratic reversed-phase HPLC was performed on a C18 column with methanol-water-acetic acid, 67:32:1 (v/v), as mobile phase and UV detection at 230 nm. Calibration curves were linear over the concentration range 100-1000 žg mL-1 with a good correlation coefficient (0.9993) and a coefficient of variation of 1.5%. Gas chromatography was performed on an OV-17 packed column with temperature programming and flame-ionization detection. The lower limit of determination by HPLC and GC was 4 ppm. Thin-layer chromatography of nimesulide was performed on silica gel G with toluene-ethyl acetate, 8:2, as mobile phase. Stability testing of the drug was performed under different temperature, humidity, and UV-radiation conditions.

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2002
• Tom: No. 12
• Strony: 95--103
• Opis fizyczny: Bibliogr. 11 poz., rys., tab.

Twórcy

autor

Syed A. A.

• Department of Studies in Chemistry, University of Mysore, Manasagangotri, Mysore-570 006, India

autor

Amshumali M. K.

• SBD Institute of Pharmacy, 1st Cross, Hanumanthanagar, Bangalore-560019, India

autor

Devan N.

• Department of Organic Chemistry, Indian Institute of Science, Bangalore-560012, India

Bibliografia

• [1] The Merck Index, 12th edn, Merck Research Laboratories, White House Station, NJ, USA 1996, p. 1125
• [2] S. Sengupta, T. Velpandian, S. R. Kabir, and S. K. Gupta, Eur. J. Clin. Pharmacol., 54, 541 (1998)
• [3] A. Nonzioli, G. Luque, and C. Fernandez., J. High Resol. Chromatogr., 12, 413 (1989)
• [4] A. Alvarez-Lueje, P. Vasquez, L. T. Nunez-Vergara, and J. A. Squella, Anal. Lett., 31, 1173 (1998)
• [5] M. Carini , G. Aldini, R. Stefani, and C. Marinello, J. Pharm. Biomed. Anal., 18, 201 (1998)
• [6] C. Giachetti and A. Tenconi, Biomed. Chromatogr., 12, 50 (1998)
• [7] D. Castoldi, V. Monzani, and O. Tofanetti, J. Chromatogr., 425, 413 (1988)
• [8] A. Auteri, M. Saletti, P. Blardi, and T. Diperri, Int. J. Tissue. React., 10, 217 (1988)
• [9] Federal Register, 43, 45077 (1978)
• [10] Proposed Guidelines for Stability Studies for Human Drugs and Biologicals, Food and Drug Administration, Washington DC, March (1984)
• [11] L. Kenon, J. Pharm. Sci., 53, 815 (1964)