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Volume: 9, Issue: 8, August, 2019
DOI: 10.7324/JAPS.2019.90810

Research Article

Identification and quantitation of related substances of super potent steroid in its topical combination drug product with vitamin D3 analogue

NVVSS Narayana Murty Nagulakonda1 & 2, Kali Krishna Praveen Gadde1, Krishnamurthy Tatikonda1, Nageswara Rao Gollapalli2

  Author Affiliations


Clobetasol propionate is an internationally accepted common name for 21-chloro-9-fluoro-11beta,17-dihydroxy- 16beta-methylpregna-1,4-diene-3,20-dione 17-propionate. The combination of calcipotriol (vitamin D3 analogue) and clobetasol propionate (super potent steroid) is being used as a topical formulation for the treatment of psoriasis from several years. In this work, an ultra-high performance liquid chromatography equipped with photodiode array detector and a mass compatible mobile phase in a gradient elution is employed for the separation of five related substances in presence of calcipotriol and its two impurities with a last eluting impurity in less than 11 minutes. A simple and efficient sample extraction procedure was developed to achieve the highest sensitivity as of today with limit of detection and limit of quantitation of 0.03% and 0.10%, respectively, as required by industry for drug product of clobetasol propionate and its combination products. Stationary phase with fused core particle technology is employed for the separation of impurities. Precision of the method is found to be less than 1.0% Relative standard deviation (RSD). The correlation coefficient is >0.999. Accuracy of method is ranged from 93.3% to 108.0%. This is the first reported Ultra high performance liquid chromatography (UHPLC) method for the estimation of five related substances of clobetasol propionate in its combination product with calcipotriol.


UHPLC, clobetasol propionate, calcipotriol, steroid, fused core particle.

Citation: Nagulakonda NNM, Gadde KKP, Tatikonda K, Gollapalli NR. Identification and quantitation of related substances of super potent steroid in its topical combination drug product with vitamin D3 analogue. J Appl Pharm Sci, 2019; 9(08):071–078.

Copyright: The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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