An HPLC method to evaluate purity of a steroidal drug, loteprednol etabonate

Journal of Pharmaceutical and Biomedical Analysis

Volumn 36, Issue 2, 2004, Pages 309-316

  Yasueda, Shin Ichi ^a   Higashiyama, Masayo ^a   Shirasaki, Yoshihisa ^a   Inada, Katsuhiro ^a   Ohtori, Akira ^a  

^a SENJU PHARMACEUTICAL CO LTD   (Japan)

Author keywords

High performance liquid chromatography; Impurity; Loteprednol etabonate; Validation

Indexed keywords

CHLOROMETHYL 17ALPHA ETHOXYCARBONYLOXY 11BETA HYDROXY 1 METHYL 3 OXO 6(5,10ALPHA) ABEO 19 NORANDROSTA 1,4 DIENE 17BETA CARBOXYLATE; CHLOROMETHYL 17ALPHA ETHOXYCARBONYLOXY 11BETA HYDROXY 5ALPHA METHYL 2 OXO 19 NORANDROSTA 1(10),3 DIENE 17BETA CARBOXYLATE; CHLOROMETHYL BETA 11BETA EPOXY 17ALPHA ETHOXYCARBONYLOXY 2 OXO 10ALPHA ANDROST 4 ENE 17BETA CARBOXYLATE; DRUG METABOLITE; LOTEPREDNOL ETABONATE; PJ 90; PJ 91; STEROID; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; CALIBRATION; CORRELATION COEFFICIENT; DRUG DETERMINATION; DRUG IMPURITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PHOTODEGRADATION; PRIORITY JOURNAL; REPRODUCIBILITY; ULTRAVIOLET SPECTROSCOPY; VALIDATION PROCESS;

ANDROSTADIENES; ANTI-INFLAMMATORY AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; HEAT; LIGHT; REPRODUCIBILITY OF RESULTS; SOLUTIONS; STRESS, MECHANICAL; SUSPENSIONS; TABLETS;

EID: 5644294743     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2004.06.006     Document Type: Article

References (16)

1. Druzgala P., Hochhaus G., Bodor N. J. Steroid Biochem. Mol. Biol. 38:1991;149-154
2. Bodor N. Trends Pharmac. Sci. 3:1982;53-56
3. N. Bodor, in: E. Christophers (Ed.), Topical Corticosteroid Therapy: A Novel Approach to Safer Drugs, Raven, New York, 1988, pp. 13-25.
4. Druzgala P., Bodor N. Synth. Com. 20:1990;1133-1141
5. Hochhaus G., Chen L.S., Ratka A., Druzgala P., Howes J., Bodor N., Derendorf H. J. Pharm. Sci. 81:1992;1210-1215
6. Bodor N., Wu W.M., Murakami T., Engel S. Pharm. Res. 12:1995;875-879
7. Bodor N., Wu W.M. Curr. Eye Res. 11:1992;525-530
8. ICH, Q3A(R): Impurities in New Drug Substances, Step 4, 2002.
9. ICH, Q2A: Text on Validation of Analytical Procedures, Step 4, 1994.
10. Druzgala P., Wu W.M., Bodor N. Curr. Eye Res. 10:1991;933-937
11. Reddy I.K., Khan M.A., Wu W.M., Bodor N.S. J. Ocul. Pharmacol. Ther. 12:1996;159-167
12. Bodor N., Loftsson T., Wu W.M. Pharm. Res. 9:1992;1275-1278
13. Shirasaki Y., Inada K., Inoue J., Nakamura M. Steroids. 69:2004;23-34
14. ICH, Q2B: Validation of Analytical Procedures: Methodology, Step 4, 1996.
15. Williams J.R., Moore R.H., Li R., Weeks C.M. J. Org. Chem. 45:1980;1324-1331
16. Ogata M., Noro Y., Yamada M., Tahara T., Nishimura T. J. Pharm. Sci. 87:1998;91-95