SIMULTANEOUS DETERMINATION OF HALOBETASOL PROPIONATE AND SALICYLIC ACID RELATED SUB-STANCES IN OINTMENT FORMULATION AND IDENTIFI-CATION OF IMPURITIES.

Authors

  • S.KUMARAVEL Research Scholar, Department of Pharmacy,Prist University, Thanjavur, Tamilnadu ,India
  • N.DELHI RAJ Department of Pharmaceutical Chemistry, Surya School of pharmacy,Vikravandi,Tamilnadu , India
  • S.ANBAZHAGAN Department of Pharmaceutical Chemistry, Surya School of pharmacy,Vikravandi,Tamilnadu , India
  • P.SHANMUGAPANDIYAN Department of Pharmaceutical Analysis, Rao’s College of Pharmacy, Nellore, Andhra Pradesh, India.

Keywords:

Halobetasol, Salicylic acid, INERTSIL ODS C18, Orthophosphoric acid, Acetonitrile, ICH Guidelines

Abstract

A rapid and precise RP-HPLC method for determination of Halobetasol and Salicylic acid in bulk and pharmaceutical dosage forms. Halobetasol and Salicylic acid are found to be degraded together under different set of conditions as followed according to ICH guidelines and the degradants so formed along with Halobetasol and Salicylic acid are separated by using INERTSIL ODS C18 3V (250 x 4.6, 5µ) using 1ml orthophosphoric acid in one litre water and acetonitrile as mobile phase using a gradient program with a flow rate of 1ml/min with a detection wavelength of 231 nm for both the compounds with a injection volume of 10µl. The method was validated for selectivity, linearity, accuracy, robustness, precision and specificity.  The results were indicating the method was selective in analysis of both Halobetasol and Salicylic acid in the presence of degradation products formed under various stress conditions.

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References

G. Lunn, HPLC Methods for Recently Approved Pharmaceuticals, John Wiley & Sons,2005,306-315.

Mostafa AA, Bebawy LI, Refat HH. “A spectrophotomtric determination of clobetasol propionate, Halobetasol propionate, quinagolide hydrochloride, through Charge transfer complexation”, J. Pharm. Biomed. Anal, 2002, 27: 889-899.

Nkam, R.A., Mukkanti, K., Durgaprasad, S., Naidu, P.V.L.; Simultaneous determination of halobetasol propionate and fusidic acid related substances by reversed phase high performance liquid chroma-tographic method; Asian Journal of Chemistry, 2010; 22: 3376–3380.

United State Pharmacopeia. USP-35-NF-30, 2011. http://www.uspnf.com/.

Published

2016-06-20
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How to Cite

S.KUMARAVEL, N.DELHI RAJ, S.ANBAZHAGAN, and P.SHANMUGAPANDIYAN. “SIMULTANEOUS DETERMINATION OF HALOBETASOL PROPIONATE AND SALICYLIC ACID RELATED SUB-STANCES IN OINTMENT FORMULATION AND IDENTIFI-CATION OF IMPURITIES.”. International Journal of Pharmaceutics and Drug Analysis, vol. 4, no. 6, June 2016, pp. 276-80, https://www.ijpda.org/index.php/journal/article/view/235.

Issue

Volume-4, Issue-6, June-2016

Section

Research Articles
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