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Development and validation of a stability-indicating LC-UV method for rapid analysis of buspirone in pharmaceutical dosage forms

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
An accurate, sensitive, precise, rapid and isocratic reversed-phase HPLC (RPHPLC) method for analysis of buspirone in the bulk drug and in solid dosage formulations has been developed and validated. The best separation was achieved on a 250 mm × 4.6 mm i.d., 5-μm particle, RP C 18 column with 70:30 ( υ/υ ) methanol-0.01 M sodium dihydrogen phosphate buffer (pH 3.5) as mobile phase at a flow rate of 0.8 mL min -1. UV detection was at 244 nm. Response was a linear function of concentration over the range 0.05–20 μg mL -1 ( r = 0.9998) and the limits of detection and quantitation were 3.7 and 11.3 ng mL -1, respectively. The method was validated in accordance with ICH guidelines. The drug was subjected to oxidative, hydrolytic, photolytic, and thermal stress. Degradation products produced as a result of this stress did not interfere with detection of buspirone and the assay can thus be regarded as stability-indicating. The method was used for quantification of buspirone in commercial buspirone tablets and to check content uniformity. The excipients present in the formulation did not interfere with the assay. The method is suitable for application in quality-control laboratories, because it is simple and rapid with good accuracy and precision.
Rocznik
Strony
283--297
Opis fizyczny
Bibliogr. 36 poz., rys., tab.
Twórcy
autor
  • Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India
autor
  • Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India
autor
  • Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India
autor
  • Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India
autor
  • Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India
autor
  • Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India
  • Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India
Bibliografia
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  • [13] S-H. Cho, H-W. Lee, H-T. Im, W-S. Park, Y-W. Choi, J-H. Rew, and K-T. Lee, Rapid Commun. Mass Spectrom., 20 , 1293, (2006)
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  • [22] A. Khedr and A. Sekr, J. Chromatogr. Sci., 37 , 462 (1999)
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  • [24] Z. Plotkowiak, J. Cybulski, M. Popielarz-Brzezinska, A. Grzeszkiewicz, I. Centrowska, and A. Kalska-Kowalska, Chem. Anal., 41 , 983 (1996)
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  • [26] J.A. Squella, Y. Borges, L. Bobadilla, and L.J. Nunez-Vergara, Electroanal. J., 4 , 333 (1990)
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  • [29] V.C. Jacob, S.N. Murthy, J. Saravanan, and J. Ravishankar, Indian Drugs, 34 , 24 (1997)
  • [30] International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), November 2005
  • [31] S.C. Chow and J. Shao, Statistics in Drug Research: Methodologies and Recent Developments, Marcel Dekker, 2002, pp. 31–52
  • [32] M. Zeaiter, J.M. Roger, V.B. Maurel, and D.N. Rutledge, Trends Anal. Chem., 23 , 157 (2004)
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  • [34] ICH, Stability Testing of New Drug Substances and Products (Q1AR). International Conference on Harmonisation, IFPMA, Geneva, 2000
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  • [36] International Conference on Harmonization (ICH), Guidance for Industry, Q1A (R2): Stability Testing of New Drug Substances and Products, IFPMA, Geneva, 2003
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-18f5460e-4336-41f7-9eea-2c8bbb68b33a
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