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Development and validation of a high-performance thin-layer chromatographic—densitometric method for the analysis of miconazole in creams

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A new high-performance thin-layer chromatographic (HPTLC)—densitometric method which can be employed in the routine analysis of miconazole in creams has been developed and validated as per the International Conference on Harmonization (ICH) guidelines and the United States Pharmacopeia (USP) guidance. The method involves the use of a mobile phase composed of safer reagents for both the user and the environment than the previously available methods. In this method, ethyl acetate—ammonia solution 25% (25:0.5 v/v) was an optimum composition of a solvent system on precoated HPTLC silica gel 60 F254 glass plates with a saturation time of 25 min and migration rate of 10.5 min per 70 mm migration distance. The RF value was 0.57 with no interferences from excipients or solvents at the detection wavelength of 228 nm. The relative standard deviation (RSD) values of 1.14 and 1.98 were obtained for repeatability and intermediate precision, respectively, of the method. The polynomial R2 values computed on three successive days for linearity testing were 0.984, 9.81, and 0.992. Accuracy values between 97.95% and 106.86% were obtained when testing was performed at 80%, 100%, and 120% concentration levels. The method is of acceptable selectivity and reproducibility as well as of easy use.

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Masota, N.E., Tibalinda, P., Shedafa, R. et al. Development and validation of a high-performance thin-layer chromatographic—densitometric method for the analysis of miconazole in creams. JPC-J Planar Chromat 29, 469–473 (2016).

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