International Journal of Applied Science and Engineering
Published by Chaoyang University of Technology

Hiral N. Davea, Ashlesha G. Makwana1,b, Chaitanya Bhattb, and Killambi Pundarikakshudua  

L. J. Institute of Pharmacy, Nr. Nagdev kalyan Mandir, Sanand Cross road, Ahmedabad, Gujarat, India.
K.B. Institute of Pharmaceutical Education and Research, GH/6, Sector-23, Gandhinagar, Gujarat, India.


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ABSTRACT


A sensitive, accurate, precise and reliable HPTLC method has been proposed for determination of Ciclesonide and Fluticasone propionate - two widely used novel steroids in bulk as well as in pressurized metered dose preparations. Ciclesonide and Fluticasone propionate resolved well in toluene: ethyl acetate: formic acid (7: 3: 0.1 v/v/v) with respective Rf values 0.46 ± 0.004 and 0.43 ± 0.012 and could be scanned at 242 nm and 236 nm respectively. Linearity was observed in the range of 400 – 1100 ng band-1 for Ciclesonide and 200 – 1000 ng band-1 for Fluticasone propionate. The method was validated as per ICH guidelines and successfully applied for quantification of Ciclesonide and Fluticasone propionate in their commercial metered dose formulations. The method was found to be less time consuming as well as cost effective for routine analysis.


Keywords: Ciclesonide; Fluticasone propionate; High Performance Thin Layer Chromatography; pressurized metered - dose preparations; Respiratory disorders


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REFERENCES


  1. [1] Indian Pharmacopoeia, (Published by Indian Pharmacopoeia Commission- Ghaziabad), 2007, 1: 930-931.

  2. [2] Indian Pharmacopoeia, (Published by Indian Pharmacopoeia Commission – Ghaziabad), 2007, 1: 1142-1143.

  3. [3] Maschera, H. J., Zechb, K., and Maschera, D. G. 2008. Sensitive simultaneous determination of ciclesonide, ciclesonide-M1-metabolite and fluticasone propionate in human serum by HPLC–MS/MS with APPI. Journal of Chromatography B, 869, 1-2: 84-92.

  4. [4] Dave, H. N., and Makwana, A. G. 2010. Rapid Spectrophotometric methods for the determination of two novel steroids in bulk and pressurised metered - dose preparations. International Journal of Pharmacy and Health Sciences, 1, 2: 68-76.

  5. [5] Laugher, L., Noctor, T. G., Barrow, A., Oxford, J. M., and Phillips, T. 1999. An improved method for the determination of fluticasone propionate in human plasma. Journal of Pharmaceutical and Biomedical Analysis, 21, 4:749-58.

  6. [6] Murnane, D., Martin, G. P., and Marriott, C. 2006. Validation of a reverse-phase high performance liquid chromatographic method for concurrent assay of a weak base - salmeterol xinafoate and a pharmacologically active steroid fluticasone propionate. Journal of Pharmaceutical and Biomedical Analysis, 40, 5: 1149-54.

  7. [7] Ayad, M. M., Henawee, M. M., Abdellatef, H. E., and Sayed, H. 2005. Spectrophotometric Determination Of Levonorgestrel, Norethisterone Acetate, Mometasone Furoate And Fluticasone Propionate Using 4 amino-antipyrine. Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Egypt, 43, 3: 24-28.

  8. [8] Trivedi, P. D. and Kilambi P. 2007. A Validated High Performance Thin - layer Chromatographic method for the estimation of gymnemic acids through gymnemagenin in Gymnema sylvestre, materials, extracts and formulations. International Journal of Applied Science and Engineering, 6, 1: 19-28.

  9. [9] ICH TOPIC Q2B 1996. “Validation of Analytical Procedures: Methodology”, London.

  10. [10] Indian Pharmacopoeia, (Published by Indian Pharmacopoeia Commission- Ghaziabad), 2007, 1: 639-652.


ARTICLE INFORMATION




Accepted: 2011-07-04
Available Online: 2011-09-01


Cite this article:

Dave, H.N., Makwana, A.G., Bhatt, C., Pundarikakshudu, K. 2011. Validated HPTLC method for the determination of two novel steroids in bulk and pressurized metered-dose preparations. International Journal of Applied Science and Engineering, 9, 177–185. https://doi.org/10.6703/IJASE.2011.9(3).177