[ Pharmaceutical Sciences Asia - ONLINE ]
Print ISSN 2586-8195 E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974


DOI: https://doi.org/10.14456/mujps.2016.24Pharm Sci Asia 2016; 43(4), 211-221

Development and validation of high-performance liquid chromatography method for determination of miconazole, triamcinolone, methylparaben and propylparaben in cream

Z.Z. Ei, J. Pimthon, O. Vajragupta, J. Leanpolchareanchai and C.M. Phechkrajang*

1 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayuthaya Rd., Payathai, Rachatevi, Bangkok, 10400. Thailand
2 Excellent Center for Innovation in Drug Design and Discovery, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayuthaya Rd., Payathai, Rachatevi, Bangkok, 10400. Thailand
3 Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayuthaya Rd.,Payathai, Rachatevi, Bangkok, 10400. Thailand

A simple, precise and accurate reversed-phase high performance liquid chromatographic method was developed for simultaneous determination of miconazole (MIC), triamcinolone (TRI), methylparaben (MEP), propylparaben (PRP) in cream using finasteride (FNT) as an internal standard. The complete separation of the compounds was achieved on a Symmetry© C8 column (150 x 4.6 mm, 5 ?m, particle size) with an isocratic elution using a mixture of 5 mM trichloroacetic acid in 0.05% phosphoric acid and acetonitrile (52 : 48 % v/v) as the mobile phase. The mobile phase flow rate was 0.9 mL/min. The UV detection wavelength was at 264 nm. All compounds were separated within 8.0 min. Analytical performance of the intended HPLC procedure was validated for system suitability, accuracy, intermediate precision, repeatability, specificity, linearity and range according to ICH guideline. The percent recoveries were 100.7-104.6 % for MIC and 97.1-99.6 % for TRI. Repeatability and intermediate precision presented as % RSD values were less than 6.1 and 1.8, respectively. The specificity results demonstrated that the determination of MIC and TRI in cream could be performed without interferences from other excipients. The regression for the calibration curve showed linear relationship with the square of correlation coefficient (r) value of MIC and TRI, 0.9988 and 0.9982, respectively, in the concentration ranges of 0.05 to 0.5 mg/mL for MIC and 0.005 to 0.05 mg/mL for TRI. This method has been applied for quantitative determination of MIC and TRI cream formulations obtained from local drugstore.


Miconazole, Triamcinolone, Cream, HPLC

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