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Sci Pharm. 2013 Apr-Jun;81(2):505-18. doi: 10.3797/scipharm.1301-21. Epub 2013 Feb 25.

Development and Validation of a Novel Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Halometasone, Fusidic Acid, Methylparaben, and Propylparaben in Topical Pharmaceutical Formulation.

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Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500 072, India. ; Singhania University, Pacheri Bari, Dist. Jhunjhunu, Rajasthan-333 515, India.


A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of halometasone, fusidic acid, methylparaben, and propylparaben in topical pharmaceutical formulation. The desired chromatographic separation was achieved on an Agilent Zorbax CN (Cyano), 5 μm (250 × 4.6 mm) column using gradient elution at 240 nm detector wavelength. The optimized mobile phase consisted of a mixture of 0.01 M phosphate buffer and 0.1% orthophosphoric acid, pH-adjusted to 2.5 with an ammonia solution as solvent-A and acetonitrile as solvent-B. The developed method separated halometasone, fusidic acid, methylparaben, and propylparaben in the presence of known impurities/degradation products. The stability-indicating capability was established by forced degradation experiments and separation of known and unknown degradation products. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method was applied for the simultaneous estimation of HM, FA, MP, and PP in commercially available cream samples. Further, the method can be extended for the estimation of HM, FA, MP, and PP in various commercially available dosage forms.


Assay; Forced degradation; HPLC; Halometasone Monohydrate; Method validation; Methylparaben; Propylparaben; Topical formulation

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