Development and validation of an RP-HPLC-UV method for analysis of sumatriptan succinate in pharmaceutical dosage forms

• Autorzy: Ravi S. , Darwis Y , Khan N
• Języki publikacji: EN

Abstrakty

EN

An isocratic RP-HPLC-UV method for analysis of sumatriptan succinate in pharmaceutical dosage forms has been developed and validated. Best separation was achieved on a Thermo Hypersil C4 column (250 mm × 4.6 mm, 5 µm) using a mobile phase of 20 mM potassium dihydrogen phosphate adjusted to pH 4.0 with orthophosphoric acid and acetonitrile (65:35, v/v) at a flow rate of 1.0 mL min ^-1. UV detection was performed at 227 nm. The method was validated for specificity, linearity, precision, accuracy, limit of quantification, limit of detection, robustness, and solution stability. The calibration plot was linear over the concentration range 25–600 ng mL ^-1 (r ²= 0.9998) and the limits of detection and quantification were 10 and 25 ng mL ^-1, respectively. Intra-day and inter-day precision and accuracy were between 1.25 and 2.95% and between −1.15 and 2.47%, respectively. The method was successfully used for analysis of sumatriptan succinate, in the presence of excipients, in orally disintegrating tablets prepared in our laboratory and in commercially available tablets (Imigran) and nasal spray (Suminat).

Słowa kluczowe

EN

sumatriptan succinate; RP-HPLC-UV; method validation; pharmaceutical dosage forms

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2009
• Tom: Vol. 21, no. 3
• Strony: 421--432
• Opis fizyczny: Bibliogr. 19 poz., rys., tab.

Twórcy

autor

Ravi S.

• University of Science Malaysia School of Pharmaceutical Sciences 11800 Pulau Penang Malaysia [e-mail]

autor

Darwis Y

autor

Khan N

• University of Science Malaysia School of Pharmaceutical Sciences 11800 Pulau Penang Malaysia [e-mail]

Bibliografia

• [1] B.D. Dulery, M.A. Petty, J. Schoun, M. David, and N.D. Huebert, J. Pharm. Biomed. Anal., 15 , 1009 (1997)
• [2] M.J. Nozal, J.L. Bernal, L. Toribio, M.T. Martin, and F.J. Diez, J. Pharm. Biomed. Anal., 30 , 285 (2002)
• [3] C. Balaguer-Fernandez, A. Femenia-Font, S.D. Rio-Sancho, V. Merino, and A. Lopez-Castellano, J. Pharm. Sci., 97 , 2102 (2008)
• [4] A. Femenia-Font, V. Merino, V. Rodilla, and A. Lopez-Castellano, J. Pharm. Biomed. Anal., 37 , 621 (2005)
• [5] A. Femenia-Font, C. Balaguer-Fernandez, V. Merino, V. Rodilla, and A. Lopez- Castellano, Eur. J. Pharm. Biopharm., 61 , 50 (2005)
• [6] J. Klancke, Dissolut Technol., 10 , 6 (2003)
• [7] V.A. Shrisat, S.Y. Gabhe, and S.G. Deshpande, Indian Drugs, 35 , 404 (1998)
• [8] S. Sukhdev and R. Jain, Indian Drugs, 34 , 527 (1997)
• [9] N. Badwe and N. Sharma, Eastern Pharmacist, XL , 121 (1997)
• [10] S.S. Shidhaye, N.S. Saindane, P.V. Thakkar, S.B. Sutar, and V.J. Kadam, Indian J. Pharm. Sci., 69 , 729 (2007)
• [11] A.B. Avadhanulu, J.S. Srinivas, and Y. Anjaneyulu, Indian Drugs, 33 , 334 (1996)
• [12] D.N. Tipre and P.R. Vavia, Indian Drugs, 36 , 501 (1999)
• [13] L.I. Bebawy, A.A. Moustafa, and N.F. Abo-Talib, J. Pharm. Biomed. Anal., 32 , 1123 (2003)
• [14] K. Sagar, J.M.F. Alvarez, C. Hua, M.R. Smyth, and R. Munden, J. Pharm. Biomed. Anal. 10 , 17 (1992)
• [15] K.D. Altria and S.D. Filbey, Anal. Proc., 30 , 363 (1993)
• [16] K.D. Altria and S.D. Filbey, J. Liq. Chromatogr. Relat. Technol., 16 , 2281 (1993)
• [17] International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), November 2005
• [18] USFDA. Validation of Chromatographic Methods. US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Rockville, MD, November 1994.
• [19] USFDA. Inactive Ingredients Search for Approved Product Drugs, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Rockville, MD, January, 2008 ( http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm ).