Evaluation of an HPLC test for impurities in the corticosteroid, 11β,21-dihydroxy-pregna-1,4-diene-3,20-dione[17a,16a-d]2′- methyloxazoline-21-acetate

Journal of Liquid Chromatography and Related Technologies

Volumn 27, Issue 12, 2004, Pages 1915-1924

  B'Hymer, C ^a  

^a UNIVERSITY OF CINCINNATI   (United States)

Author keywords

Drug analysis; Gradient HPLC; Impurity test; Steroid

Indexed keywords

ACETONITRILE; CHEMICAL ANALYSIS; COMPOSITION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ULTRAVIOLET DETECTORS;

CORTICOSTEROID; IMPURITY LEVEL; SODIUM PHOSPHATE;

IMPURITIES;

11BETA,21 DIHYDROXYPREGNA 1,4 DIENE 3,20 DIONE 2' METHYLOXAZOLINE 21 ACETATE; ACETONITRILE; CORTICOSTEROID; SODIUM DIHYDROGEN PHOSPHATE; UNCLASSIFIED DRUG; WATER;

ACCURACY; ANALYTIC METHOD; ARTICLE; DRUG IMPURITY; EVALUATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; VALIDATION PROCESS;

EID: 3042563661     PISSN: 10826076     EISSN: None     Source Type: Journal    
DOI: 10.1081/JLC-120038777     Document Type: Article

References (12)

1. The 2002 United States Pharmacopoeia XXXV and National Formulary XX; The United States Pharmacopoeia Convention, Inc.: Rockville, Maryland, 2001.
2. Volin, P. High performance liquid chromatographic analysis of corticosteroids. J. Chromatogr. B 1995, 671 (1-2), 319-340.
3. Indrayanto, G.; Yuwono, M. Steriod analysis by gas chromatography. Encyclopedia Chromatogr. 2003, 9, 1-5.
4. Shah, J.A.; Weber, D.J. Simultaneous determination of methylprednisolone and methylprednisolone 21-[8-[methyl-(8-methyl-(2-sulfonethyl)-amino]-8- oxooctanote] sodium salt in human urine by high performance liquid chromatography with ultraviolet detection. J. Chromatogr. 1989, 434 (1), 125-254.
5. Gradner, R.S.; Walker, M.; Hollingsbee, D.A. A sensitive high performance liquid chromatographic method for the assessment of percutaneous absorption of topical corticosteroids. J. Pharmaceut. Biomed. B. 1990, 8 (8-12), 1083-1085.
6. Marini, R.D.; Pantella, A.; Bimazubute, M.A.; Chiap, P.; Hubert, P.; Crommen, J. Optimisation and validation of a generic method for the LC assay of six corticosteroids and salicylic acid in dermopharmaceutical forms. Chromatographia 2002, 5 (5-6), 263-269.
7. McBride, J.H.; Rodgerson, D.O.; Park, S.S.; Reyes, A.F. Rapid Liquid Chromatographic method for simultaneous determination of plasma prednisone, prednisolone and cortisol in pediatric renal-transplant recipients. Clin. Chem. 1991, 37 (5), 643-646.
8. Shalaby, A.; Shahjahan, M. Improved high performance liquid chromatographic method for the determination of some corticosteroids. J. Liq. Chromatogr. 1991, 14 (7), 1267-1274.
9. Hajkova, R.; Solich, P.; Dvorak, J.; Sicha, J. Simultaneous determination of methylparaben, propylparaben, hydrocortisone acetate and its degradation products in a topical cream by RP-HPLC. J. Pharm. Biomed. Anal. 2003, 32 (4-5), 921-927.
10. Walsh, P.M. Ed. Physicians' Desk Reference, 57th Ed.; Thomson PDR: Montvale, NJ, 2003; 2005-2006.
11. Sweetman, S.C. Ed. Martindale: The Complete Drug Reference, 33rd Ed.; Pharmaceutical Press: London, 2002; 1039-1040.
12. Green, M.J. A practical guide to analytical method validation. Anal. Chem. 1996, 68, 305A-309A.