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Development and validation of a high-performance thin-layer chromatographic—densitometric method for the analysis of miconazole in creams

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Summary

A new high-performance thin-layer chromatographic (HPTLC)—densitometric method which can be employed in the routine analysis of miconazole in creams has been developed and validated as per the International Conference on Harmonization (ICH) guidelines and the United States Pharmacopeia (USP) guidance. The method involves the use of a mobile phase composed of safer reagents for both the user and the environment than the previously available methods. In this method, ethyl acetate—ammonia solution 25% (25:0.5 v/v) was an optimum composition of a solvent system on precoated HPTLC silica gel 60 F254 glass plates with a saturation time of 25 min and migration rate of 10.5 min per 70 mm migration distance. The RF value was 0.57 with no interferences from excipients or solvents at the detection wavelength of 228 nm. The relative standard deviation (RSD) values of 1.14 and 1.98 were obtained for repeatability and intermediate precision, respectively, of the method. The polynomial R2 values computed on three successive days for linearity testing were 0.984, 9.81, and 0.992. Accuracy values between 97.95% and 106.86% were obtained when testing was performed at 80%, 100%, and 120% concentration levels. The method is of acceptable selectivity and reproducibility as well as of easy use.

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References

  1. USP–NF [internet] [cited 2015 Jul 19], available from: http://www.usp.org/usp-nf.

  2. The Harriet Lane Handbook, A Manual for Pediatric House Officers, 19th edn., Elsevier Mosby, Philadelphia, PA, 2012.

  3. WHO, Quality Assurance of Pharmaceuticals, WHO Expert Committee on Specifications for Pharmaceutical Preparations, thirty-sixth report, Geneva, 2007; 2: Quality Assurance of Pharmaceuticals, pp. 17–57.

  4. E. Kaale, Pharm. Anal. Acta 4 (2013) 1–4.

    Article  Google Scholar 

  5. D.B. Meshram, S.B. Bagade, M.R. Tajne, J. Pak, Pharm. Sci. 22 (2009) 323–328.

    CAS  Google Scholar 

  6. A.J. Patel, D.M. Joshi, M.S. Choyal, B.D. Patel, Asian J. Pharm. Anal. 5 (2015) 49–60.

    Article  Google Scholar 

  7. K.A. Shah, J.B. Dave, World J. Pharm. Pharm. Sci. 4 (2015) 1156–1172.

    CAS  Google Scholar 

  8. P.K. Pagare, C.S. Satpute, V.M. Jadhav, V. Kadam, Pharm. Lett. 4 (2012) 1793–1804.

    CAS  Google Scholar 

  9. P.S. Malani, H.A. Raj, V.C. Jain, Pharma Sci. Monit. 5 (2014) 386–399.

    Google Scholar 

  10. J. Sekizawa, Bull. Natl. Inst. Hyg. Sci. 1 (1996) 89–94.

    Google Scholar 

  11. A. Abou-Elkheir, H.M. Saleh, M.M. El-Henawee, B.S. Ghareeb, M.S. Mohram, Indo Am. J. Pharm. Res. 5 (2015) 641–653.

    CAS  Google Scholar 

  12. D.R. Sahoo, S. Jain, J. Chromatogr. Sci. 1 (2016) 1–6.

    Google Scholar 

  13. N. Erk, M.L. Altun, J. Pharm. Biomed. Anal. 25 (2001) 115–122.

    Article  CAS  Google Scholar 

  14. M.M. De Zan, M.S. Cámara, J.C. Robles, S.V. Kergaravat, H.C. Goicoechea, Talanta 79 (2009) 762–767.

    Article  Google Scholar 

  15. S. Ashour, N. Kattan, Int. J. Biomed. Sci. 6 (2010) 24–27.

    Google Scholar 

  16. E. Kaale, P. Risha, T. Layloff, J. Chromatogr. A 1218 (2011) 2732–2736.

    Article  CAS  Google Scholar 

  17. N.E. Masota, J. Sempombe, P. Tibalinda, E. Kaale, East Cent. African J. Pharm. Sci. 18 (2015) 3–9.

    Google Scholar 

  18. M.M. Srivastava (ed.), High-Performance Thin-Layer Chromatography (HPTLC), Springer Science & Business Media, Heidelberg, 2011.

    Google Scholar 

  19. United States Pharmacopeial Convention, Physical Tests: Chromatography, 38, United States Pharmacopeia, 2015, 7–8

  20. International Conference on Harmonization, Validation of Analytical Procedures: Text and Methodology Q2(R1), Guidance, Geneva, 2005.

    Google Scholar 

  21. USP Monographs: Miconazole Nitrate Cream [cited 2016 Jan 7], available from: http://www.pharmacopeia.cn/v29240/us-p29nf24s0_m54000.html.

  22. K.G. Patel, P.M. Shah, P.A. Shah, T.R. Gandhi, J. Food Drug Anal. 24 (2016) 610–619.

    Article  CAS  Google Scholar 

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Correspondence to Nelson E. Masota.

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Masota, N.E., Tibalinda, P., Shedafa, R. et al. Development and validation of a high-performance thin-layer chromatographic—densitometric method for the analysis of miconazole in creams. JPC-J Planar Chromat 29, 469–473 (2016). https://doi.org/10.1556/1006.2016.29.6.10

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  • DOI: https://doi.org/10.1556/1006.2016.29.6.10

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