Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2020 Vol: 12 Issue: 7

Optimizing the process of bromhexine determination in tablets by using the response surface methodology


Objective: The study is to establish a method for the determination of bromhexine hydrochloride in tablets. Methods: Bromhexine hydrochloride in the tablets were analyzed by a HIQ Sil C18 column (250 mm × 4.6 mm; 5 μm) with a mobile phase including methanol -0.09% acid orthophosphoric (60:40, v/v). The flow rate was 0.9 ml/min with the detection wavelength at 247 nm. Results: This method was validated according to the International Conference on Harmonisation (ICH) Q2 (R1) guideline. Calibration graph was linear (r=0.9999, n=7) in concentration range of 2-40 μg/ml. The average recovery of bromhexine hydrochloride was 99.63%, and RSD was 1.01% (n=12). Conclusions: The simple, fast, and reproducible RP-HPLC method has been successfully developed and validated. The proposed method is used for the quantitation of bromhexine in some products in the market.

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