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Concurrent Determination of Pridinol, Diclofenac and Impurity A by HPLC-UV

Journal of Chromatographic Science, ISSN: 0021-9665, Vol: 62, Issue: 1, Page: 92-99
2024
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Findings from University of Buenos Aires Broaden Understanding of Chromatographic Science (Concurrent Determination of Pridinol, Diclofenac and Impurity a By Hplc-uv)

2024 OCT 25 (NewsRx) -- By a News Reporter-Staff News Editor at Education Daily Report -- Current study results on Education - Chromatographic Science have

Article Description

A reversed-phase high-performance liquid chromatography method was developed and validated for the simultaneous determination of pridinol, diclofenac and diclofenac-related compounds in tablet formulations. The proposed method is also suitable for content uniformity determination, for dissolution test and for stability studies. Separation was achieved on a base-deactivated silica C8 column, using 50 mM phosphate buffer (pH 2.5) and methanol (40:60 v/v) as mobile phase, at a flow rate of 1.0 mL/min and column temperature of 40C. Ultraviolet detection was made at 225 nm. The method was validated for specificity, accuracy, precision (intraday and interday levels) and linearity for each analyte. For diclofenac impurity A, sensitivity was also studied. The method showed specificity and linearity (R: 0.999 for the three analytes) over the assessed concentration range (diclofenac: 2.5–75.0 μg/mL, pridinol: 2.0–60.0 μg/mL and impurity A: 1.25–5.0 μg/mL) and demonstrated good precision as reflected by the low coefficient of variation in all cases. Recovery rates obtained were 99.81, 100.58 and 100.96% for diclofenac, pridinol and impurity A respectively, and for all three analytes, the variances of the concentrations tested were equivalent. The detection and quantitation limits for impurity A were 0.078 and 0.261 μg/mL, respectively.

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