Abstract
Two simple, rapid and accurate methods for the determination of bupropion hydrochloride (BUP) in pure and in pharmaceutical preparations are described. Both methods are based on the measurement of the chloride of its hydrochloride. In the titrimetric method, the chloride content of bupropion hydrochloride is determined by titrating with mercury(II)nitrate using diphenylcarbazone–bromophenol blue as indicator. Titrimetric method is applicable over a range 2–20 mg of BUP and the reaction stoichiometry is found to be 2:1 (BUP: Hg(NO3)2). The spectrophotometric method involves the addition of a measured excess of mercury(II) nitrate reagent in formate buffer to the drug, and after ensuring the reaction had gone to completion, the unreacted mercury(II) is treated with a fixed amount of diphenylcarbazone, and absorbance measured at 515 nm. The absorbance is found to decrease linearly with increasing concentration of BUP and the calibration curve is linear over 1.0–15.0 μg mL–1 BUP. The proposed methods were successfully applied to the determination of BUP in commercially available dosage forms with good accuracy and precision, and without detectable interference by excipients. The accuracy was further ascertained by placebo blank and synthetic mixture analyses and also by recovery experiments via standard-addition procedure.
Highlights
Bupropion hydrochloride (BUP), chemically known as 1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride (Fig. 1) [1], is the water soluble salt of an aminoketone [2], with a pKa of 7.9 [3] and it is known with the generic name of amfebutamone hydrochloride
Since its introduction in 1989, the most extensively used technique for the quantitation of bupropion hydrochloride (BUP) is HPLC but, most of the procedures using this technique are devoted to biological fluids like plasma [7, 8, 9], plasma and serum [10] and dog plasma [11]
Even such techniques as radioimmunoassay [12], GC [13], LC [14, 15], LC/ESI/MS/MS [16], LC-MS [17] and LC-MS/MS [18, 19] are confined to biological fluids including dog plasma [12], human plasma [13, 14, 15], waste water [16], rat everted gut sacs [17], plasma and urine [18] and human, mouse and rat plasma [19]
Summary
Bupropion hydrochloride (BUP), chemically known as 1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride (Fig. 1) [1], is the water soluble salt of an aminoketone [2], with a pKa of 7.9 [3] and it is known with the generic name of amfebutamone hydrochloride. It was prepared by dissolving 0.52 g sodium formate (LOBA Chemie PVT LTD, Mumbai, India, assay 99.0 %) in 70 mL of distilled water, pH adjusted to 3.4 with 0.5 mol L−1 nitric acid and diluted to 100 mL with water. A stock standard solution equivalent to 2.0 mg mL-1 of BUP was prepared by dissolving accurately weighed 200 mg of pure drug in water and diluting to the mark in a 100 mL calibrated flask with water. This solution was used in titrimetric work. ML-1 of BUP was diluted appropriately with water to get a working concentration of 100 μg mL-1 BUP for use in spectrophotometric work
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