Development and Validation of RP-HPLC Method for Desoximetasone in Bulk and Cream Formulation
Desoximetasone chemically is 9-fluoro-IIβ21-dihydroxy-I6a-methylpregna-I.4-diene-3.The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. So, in present investigation chromatographic methods were developing use RP-HPLC for estimation of Desoximetasone in bulk and in cream formulation and method validation according to ICH guidelines. The main objective of this study was to develop a simple and reproducible method for desoximetasone by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). In this work the desoximetasone separation was carried out by using C18 cosmosile column (250mmx4.6mm particle size 5µm). By using 0.1% orthrophosphoric acid pH adjusted up to 3 at uv detection of 240nm.The mobile phase was used at various ratio for gradient elution the ratio of mobile phase was 20:80 v/v. Methanol and water used for mobile phase and flow rate was being set at 1mL/min. The linearity of proposed method was found in range of r =0.9989. Statistically validation parameters such as linearity, accuracy, precision, LOD and LOQ were checked.
Keywords: Desoximetasone, RP-HPLC, Method validation.
2. Willard, Metritt H. H.et.al, Dean L. L., Settal J, A., Instrumental methods of Analysis, 7thedn., CBS Publishers and Distributers, 1986, p.118.
3 Coskun O.et.al, Yerleskesi T., Binasi D., Separation techniques: Chromatography, North Clin Istanb. 2016; 3(2):156–160.
4. Skoog West D. A., Holler D. M., F. J and Crouch S. R., Fundamental of analytical chemistry, 8thedn, Thomson Brooks/Cole, 2007, pp.1-5, 355, 906-909.
5. Scott P., Principles and Practice of Chromatography, Chrome-ED Book Series; pp.1-2, 12-14.
6. Srinivas P., Sudhakarbabu K. And Sreeramulu, J., Identification, characterization of degradation component in desoximetasone pharmaceutical dosage forms and its quantification in the presence of process related impurities. Journal o K. f Liquid Chromatography & Related Technologies, 2012; 35(8):1114-1129.
7. Heel R.C., Brogden R.N., Speight T.M. and Avery G.S., Desoxymethasone: A Review of its Pharmacological Properties and Therapeutic Efficacy in the Treatment of Dermatoses. Drugs, 1978; 16(4):302-321.
8. Gali H. and Yerragunta V., Development and validation of RP-HPLC method for simultaneous estimation of naproxen and esomeprazole in pharmaceutical dosage form. Asian Journal of Research in Chemistry, 2016; 9(8):366.
9. Saravanan V, Revathi R, Meera N, Method Development and Validation for the Simultaneous Estimation of Lycopene and Ubidecarenone By RP-HPLC in Combined Pharmaceutical Dosage Form. Journal of Drug Delivery and Therapeutics, 2016; 6(5):46-51.
10. Borelli, Gassmueller C., Fluhr J., Nietsch J.W., K.H., Schinzel K.H., S. and Korting, H.C., Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay. Skin pharmacology and physiology, 2008; 21(3):181-187.
11. Sheliya, K., Shah, K. and Kapupara, P., Development and validation of analytical method for simultaneous estimation of mometasone furoate, hydroquinone and tretinoin in topical formulation by RP-HPLC. Journal of Chemical and Pharmaceutical Research, 2014’6(4):934-9408.
12. Hadad, G.M., Emara, S. and Mahmoud, W.M., Development and validation of a stability-indicating RP-HPLC method for the determination of paracetamol with dantrolene or/and cetirizine and pseudoephedrine in two pharmaceutical dosage forms. Talanta, 2009; 79(5):1360-1367.
13. ICH, Q2B, Harmonised tripartite guideline, Validation of analytical procedure: Methodology, International conference on harmonization, Geneva, Switzerland, March 1996.
14. Vladimirov S., Čudina O., Agbaba D., Jovanović M., and Živanov-Stakić D., Spectrophotometric determination of desoximetasone in ointment using 1,4-dihydrazinophthalazine. Journal of pharmaceutical and biomedical analysis, 1996; 14(8-10):947-950.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).