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Stability Indicating RP-HPLC Assessment and Stability Testing of Tazarotene and Halobetasol in Lotion Formulation
Corresponding Author(s) : V.L.N. Balaji Gupta Tiruveedhi
Asian Journal of Chemistry,
Vol. 32 No. 6 (2020): Vol 32 Issue 6
Abstract
A novel liquid chromatographic method was established and validated for the quantification of tazarotene and halobetasol in the presence of degradation products obtained during stress conditions. The liquid chromatographic method was based on isocratic elution on Knauer Eurospher II C18 (5 μm particle size, 250 mm × 4.5 mm) column using a mobile phase consisting of methanol, acetonitrile and 0.5 mM perchloric acid (40:45:15 v/v/v) mixture at flow rate of 0.9 mL/min. Quantization of tazarotene and halobetasol was done with UV detection at 234 nm. The method validity was assessed in agreement with the recommendations of the International Conference on Harmonization. Linearity, accuracy and precision were satisfactory over the concentration ranges of 2.25-13.5 and 0.5-3.0 μg/mL for tazarotene and halobetasol, respectively. Detection limit values of 0.006 μg/mL and 0.01 μg/mL were found for halobetsol and tazarotene, respectively, while the quantization limit values of 0.02 μg/mL and 0.033 μg/mL were found for halobetsol and tazarotene, respectively. The developed method is appropriate for routine analysis and quality control of tazarotene and halobetasol combination in lotion dosage form.
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- Tazoretene. Drug bank, Accessed on November 2019. Available at: https://www.drugbank.ca/drugs/DB00799.
- Tazoretene. Pubchem, U.S. National Library of Medicine, Accessed on November 2019. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/Tazarotene.
- G. Weindl, A. Roeder, M. Schäfer-Korting, M. Schaller and H.C. Korting, Am. J. Clin. Dermatol., 7, 85 (2006); https://doi.org/10.2165/00128071-200607020-00002
- S. Ogden, M. Samuel and C.E. Griffiths, Clin. Interv. Aging, 3, 71 (2008); https://doi.org/10.2147/CIA.S1101
- E. Tanghetti, M. Lebwohl and L.S. Gold, J. Drugs Dermatol., 17, 1280 (2018).
- S. Gregoriou, E. Kritsotaki, A. Katoulis and D. Rigopoulos, Clin. Cosmet. Investig. Dermatol., 7, 165 (2014); https://doi.org/10.2147/CCID.S37327
- G. Latter, J.E. Grice, Y. Mohammed, M.S. Roberts and H.A.E. Benson, Pharmaceutics, 11, e490 (2019); https://doi.org/10.3390/pharmaceutics11100490
- Halobetasol Cream, StatPearls [Internet]. Treasure Island (FL), StatPearls Publishing (2019). Accessed on November 2019. Available at: https://www.ncbi.nlm.nih.gov/books/NBK544234/.
- Halobestol. Pubchem, U.S. National Library of Medicine, accessed on November 2019. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/Halobetasol.
- F.A. Kerdel, Z.D. Draelos, S.K. Tyring, T. Lin and R. Pillai, J. Dermatolog. Treat., 30, 333 (2019); https://doi.org/10.1080/09546634.2018.1523362
- L.J. Green, F.A. Kerdel, F.E. Cook-Bolden, J. Bagel, T. Lin, G. Martin, R. Pillai, R. Israel and T. Ramakrishna, J. Drugs Dermatol., 17, 1062 (2018).
- Duobrii Approval History, Drugs.com, Accessed on November 2019. Available at: https://www.drugs.com/history/duobrii.html.
- N.D. Bhatia, D.M. Pariser, L. Kircik, T. Lin, S. Harris, L. Mathew and R. Pillai, J. Clin. Aesthet. Dermatol., 11, 15 (2018).
- M.G., Lebwohl, J.L. Sugarman, L.S. Gold, L. Lin and R. Israel, J. Drugs Dermatol., 18, 1012 (2019).
- International Conference on the Harmonization, ICH Harmonized Tripartite Guideline. Stability Testing of New Drug Substances and Products Q1A (R2) (2003).
- International Conference on the Harmonization, ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology, Q2 (R1) (2005).
- FDA, Reviewer Guidance: Validation of Chromatographic Methods, United States Food and Drug Administration, Silver Spring, MD, USA (2018).
- G.A. Shabir, J. Chromatogr. A, 987, 57 (2003); https://doi.org/10.1016/S0021-9673(02)01536-4
References
Tazoretene. Drug bank, Accessed on November 2019. Available at: https://www.drugbank.ca/drugs/DB00799.
Tazoretene. Pubchem, U.S. National Library of Medicine, Accessed on November 2019. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/Tazarotene.
G. Weindl, A. Roeder, M. Schäfer-Korting, M. Schaller and H.C. Korting, Am. J. Clin. Dermatol., 7, 85 (2006); https://doi.org/10.2165/00128071-200607020-00002
S. Ogden, M. Samuel and C.E. Griffiths, Clin. Interv. Aging, 3, 71 (2008); https://doi.org/10.2147/CIA.S1101
E. Tanghetti, M. Lebwohl and L.S. Gold, J. Drugs Dermatol., 17, 1280 (2018).
S. Gregoriou, E. Kritsotaki, A. Katoulis and D. Rigopoulos, Clin. Cosmet. Investig. Dermatol., 7, 165 (2014); https://doi.org/10.2147/CCID.S37327
G. Latter, J.E. Grice, Y. Mohammed, M.S. Roberts and H.A.E. Benson, Pharmaceutics, 11, e490 (2019); https://doi.org/10.3390/pharmaceutics11100490
Halobetasol Cream, StatPearls [Internet]. Treasure Island (FL), StatPearls Publishing (2019). Accessed on November 2019. Available at: https://www.ncbi.nlm.nih.gov/books/NBK544234/.
Halobestol. Pubchem, U.S. National Library of Medicine, accessed on November 2019. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/Halobetasol.
F.A. Kerdel, Z.D. Draelos, S.K. Tyring, T. Lin and R. Pillai, J. Dermatolog. Treat., 30, 333 (2019); https://doi.org/10.1080/09546634.2018.1523362
L.J. Green, F.A. Kerdel, F.E. Cook-Bolden, J. Bagel, T. Lin, G. Martin, R. Pillai, R. Israel and T. Ramakrishna, J. Drugs Dermatol., 17, 1062 (2018).
Duobrii Approval History, Drugs.com, Accessed on November 2019. Available at: https://www.drugs.com/history/duobrii.html.
N.D. Bhatia, D.M. Pariser, L. Kircik, T. Lin, S. Harris, L. Mathew and R. Pillai, J. Clin. Aesthet. Dermatol., 11, 15 (2018).
M.G., Lebwohl, J.L. Sugarman, L.S. Gold, L. Lin and R. Israel, J. Drugs Dermatol., 18, 1012 (2019).
International Conference on the Harmonization, ICH Harmonized Tripartite Guideline. Stability Testing of New Drug Substances and Products Q1A (R2) (2003).
International Conference on the Harmonization, ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology, Q2 (R1) (2005).
FDA, Reviewer Guidance: Validation of Chromatographic Methods, United States Food and Drug Administration, Silver Spring, MD, USA (2018).
G.A. Shabir, J. Chromatogr. A, 987, 57 (2003); https://doi.org/10.1016/S0021-9673(02)01536-4