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The Thai Journal of Pharmaceutical Sciences

Abstract

Background: A non-steroidal antiandrogen, flutamide (FA), has been used often to treat advanced prostate cancer. It blocks testosterone’s tendency to bind to androgen receptors inside cells in some of the target organs, such as hair follicles, the prostate gland, skin, and testicles.

Objective: The main focus of the work is to produce an economical and reliable reversed-phase high-performance liquid chromatography technique for the quantitative study of FA in bulk materials and pharmaceuticals.

Materials and Methods: The elution of FA was done by running a mobile phase prepared by mixing 10 mM ammonium formate-formic acid buffer (pH-4) with methanol in the ratio 40:60(v/v) through the Shim-pack GIST C18 column (250 mm × 4.6 mm, 5.0 μm particle size) maintained at 25°C for about 20 min at a rate of 1 mL/min. The FA eluted at around 7.7 min was detected at 230 nm using a photodiode array detector.

Result: The protocol showed an excellent linearity over the concentration range of 0.1–600 µg/mL of FA with a correlation coefficient value of 0.9991. The limits of detection and quantification were 0.03 µg/mL and 0.1 µg/mL, respectively. Using this methodology, a recovery of 99.70–99.91% of FA was achieved with relative standard deviation ranging from 0.20% to 0.35%. The accuracy and precision of the proposed methodology were assured by a relative error of 1.59%.

Conclusions: The approach was shown to be consistent for routine quality control analysis, as it effectively and accurately analyzed FA in drug formulation.

DOI

10.56808/3027-7922.3062

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