Assay and photodegradation kinetics of desonide lotion by an LC-UV stability-indicating method

Journal of Liquid Chromatography and Related Technologies

Volumn 37, Issue 14, 2014, Pages 1968-1984

  Braga, Muriele P ^a   Dalcin, Tássia C S ^b   Rosa, Priscila ^a   Codevilla, Cristiane F ^c   Silva, Cristiane B Da ^b   Rolim, Clarice M B ^b   Adams, Andréa I H ^b  

^a FEDERAL UNIVERSITY OF SANTA MARIA   (Brazil)

^b Universidade Federal de Santa Maria   (United States)

^c FEDERAL UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

Author keywords

desonide; desonide assay; desonide lotion; desonide photostability; desonide stability; LC method

Indexed keywords

CHEMICAL ANALYSIS; LIQUID CHROMATOGRAPHY;

DESONIDE; DESONIDE LOTION; EXPERIMENTAL CONDITIONS; LC-METHOD; PHOTO-STABILITY; PHOTODEGRADATION KINETICS; SECOND ORDER KINETICS; STABILITY INDICATING METHOD;

STABILITY;

DESONIDE;

ACCURACY; ARTICLE; DEGRADATION KINETICS; DRUG DETERMINATION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG STABILITY; LIGHT EXPOSURE; LIQUID CHROMATOGRAPHY; LOTION; PHOTODEGRADATION; QUALITY CONTROL PROCEDURES; QUANTITATIVE ANALYSIS; ULTRAVIOLET A RADIATION; VALIDATION PROCESS;

EID: 84898068500     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826076.2013.825855     Document Type: Article

References (24)

1. Hengge, U. R.; Ruzicka, T.; Schwartz, R. A.; Cork, M. J. Adverse Effects of Topical Glucocorticosteroids. J. Am. Acad. Dermatol. 2006, 54, 1-15.
2. Gelbard, C. M.; Herbert, A. A. Desonide Hydrogel: Advances in Vehicle Technology. Expert Rev. Dermatol. 2009, 4 (1), 23-27.
3. Hebert, A. A. The Desonide Foam Phase III Clinical Study Group. Desonide Foam 0.05%: Safety in Children as Young as 3 Months. J. Am. Acad. Dermatol. 2008, 59 (2), 334-340.
4. Wong, V. K.; Fuchs, B.; Lebwohl, M. Overview on Desonide 0.05%: A Clinical Safety Profile. J. Drugs Dermatol. 2004, 3 (4), 393-397.
5. Pujos, E.; Flament-Waton, M. M.; Paisse, O.; Grenier-Loustalot, M. F. Comparison of the Analysis of Corticosteroids Using Different Techniques. Anal. Bioanal. Chem. 2005, 381 (1), 244-254.
6. Mazzarino, M.; Torre, X.; Botrè, F. A Screening Method for the Simultaneous Detection of Glucocorticoids, Diuretics, Stimulants, Anti-Oestrogens, Beta-Adrenergic Drugs and Anabolic Steroids in Human Urine by LC-ESI-MS=MS. Anal. Bioanal. Chem. 2008, 392 (4), 681-698.
7. Dikunets, M. A.; Appolonova, S. A.; Rodchenkov, G. M. Simultaneous Determination of a Broad Spectrum of Nonconjugated Xenobiotics by High Performance Liquid Chromatography-Tandem Mass Spectrometry. J. Anal. Chem. 2009, 64 (8), 854-864.
8. Lopes, S. B.; Sarraguça, J. A.; Prior, J. A. V.; Lopes, J. A. Development of an HPLC Assay Methodology for a Desonide Cream with Chemometrics Assisted Optimization. Anal. Lett. 2012, 45, 1390-1400.
9. Iqbal, J.; Hussain, A.; Gupta, A. Photochemistry of Desonide, a Non-Fluorinated Steroidal Antiinflammatory Drug. Chem. Pharm. Bull. 2006, 54 (6), 836-838.
10. Dalla Santa, F.; Sperotto, L. E.; Braga, M. P.; Dalcin, T. C. S.; Codevilla, C. F.; Meneghini, L. Z.; Donato, E. M.; Rolim, C. M. B.; Bergold, A. M.; Adams, A. I. H. Development and Validation of a Simple Stability-Indicating LC-Method and UVA Photostability Study of Desonide Hair Lotion. Curr. Anal. Chem. 2013, 9, 659-667.
11. Tønnesen, H. H. Photostability of Drugs and Drug Formulations; CRC Press: Boca Raton, 2004.
12. ICH Q2R1. Guideline on Validation of Analytical Procedures: Text and Methodology. 2005. http://www. ich.org/fileadmin/Public-Web-Site/ICH-Products/ Guidelines/Quality/Q2-R1/Step4/Q2-R1-Gideline.pdf.
13. ICH Q1AR2. Guidance for Industry: Stability Testing of New Drug Substances and Products. 2003. http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Quality/Q1A-R2/Step4/Q1A-R2-Guideline.pdf
14. Watson, D. G. Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists, Elsevier Churchill Livingstone: Edinburgh, 2005.
15. Dejaegher, B.; Heyden, Y. V. Screening Designs (Part 2) Data Analysis. LC-GC Europe 2008, 21 (2), 1-8.
16. United States Food and Drug Administration (US-FDA). Center for Drug Evaluation and Research-Food and Drug Administration. Reviewer Guidance: Validation of Chromatographic Methods, 1994. http://www.fda.gov/downloads/Drugs/ Guidances/UCM134409.pdf
17. ICH Q1B. Guideline on Stability Testing: Photostability Testing of New Drug Substances and Products. 1996. http://www.ich.org/fileadmin/Public-Web- Site/ICH-Products/Guidelines/Quality/Q1B/Step4/Q1B-Guideline.pdf
18. Yoshioka, S.; Stella, V. J. Stability of Drugs and Dosage Forms, Kluwer Academic Publishers: New York, NY, 2002.
19. Synder, L. R.; Kirkland, J. J.; Glajch, J. L. Practical HPLC Method Development, Wiley: New York, NY, 1997.
20. Scifinder Scholar. American Chemical Society (ACS). Calculated using Advanced Chemistry Development (ACD=Labs) Software V11.02 (# 1994-2012 ACD=Labs), 2012.
21. Bakshi, M.; Singh, S. Development of Validated Stability-Indicating Assay Methods-Critical Review. J. Pharm. Biomed. Anal. 2002, 28, 1011-1040.
22. Shabir, G. A. Validation of high-Performance Liquid Chromatography Methods for Pharmaceutical Analysis. Understanding the Differences and Similarities Between Validation Requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. J. Chromatogr. A 2003, 987 (1-2), 57-66.
23. Cela, R.; Ordoñez, E. Y.; Quintana, J. B.; Rodil, R. Chemometric-Assisted Method Development in Reversed-Phase Liquid Chromatography. J. Chromatogr. A 2013, 1287, 2-22.
24. Barth, A. B.; Oliveira, G. B.; Maleisuik, M. D.; Paim, C. S.; Volpato, N. M. Stability-Indicating LC Assay for Butenafine Hydrochloride in Creams Using an Experimental Design for Robustness Evaluation and Photodegradation Kinetics Study. J. Chromatogr. Sci. 2011, 49, 512-518.