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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996 EISSN: 1596-5996
Vol. 16, No. 2, 2017, pp. 413-420
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Bioline Code: pr17054
Full paper language: English
Document type: Research Article
Document available free of charge
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Tropical Journal of Pharmaceutical Research, Vol. 16, No. 2, 2017, pp. 413-420
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Development and validation of a spectroscopic method for the simultaneous analysis of miconazole nitrate and hydrocortisone acetate in pharmaceutical dosage form
Abbas, Nasir; Arshad, Muhammad Sohail; Hussain, Amjad; Irfan, Muhammad; Ahsan, Muhammad; Rasool, Muhammad Fawad & Rehman, Muhammad Hafeez ur
Abstract
Purpose: To develop a new analytical method for the quantitative analysis of miconazole nitrate (MCN)
and hydrocortisone (HCA) in pharmaceutical creams.
Methods: The study was accomplished in three steps. In the first stage, a spectroscopic method was
developed for the simultaneous analysis of miconazole (MCN) and hydrocortisone (HCA). For this
purpose, serial dilutions of both drugs were prepared using ethanol: water (50:50) as the solvent
system. All solutions were analyzed for absorbance spectrophotometrically at 205 and 249 nm for MCN
and HCA, respectively. The method was validated for linearity, range, accuracy, precision and
robustness. A commercial formulation was also assayed by the proposed method.
Results: The absorbance data were linear over a concentration range of 1 to 12 μg/mL for MCN and 1
to 40 μg/mL for HCA, with correlation coefficient of 0.9995 and 0.9984, respectively. Limit of detection
(LOD) and of quantification (LOQ) of MCN were 0.49 and 1.49 μg/mL, respectively, and for HCA, 1.50
and 4.57 μg/mL, respectively. The assay results for the commercial formulation were within the limits
specified in British Pharmacopoeia.
Conclusion: Simultaneous quantification of miconazole (MCN) and hydrocortisone (HCA) by UV
spectroscopy provides a simple, reliable and robust method for the characterization of a mixture of the
drugs in a dosage form.
Keywords
Simultaneous analysis; Miconazole nitrate; Hdrocortisone acetate; UV-visible spectroscopy; Method validation
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