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Abstract
A novel, rapid, accurate, and sensitive automated high‐performance liquid chromatographic assay was developed to determine biotin (BI) in pharmaceutical dosage forms and to follow its dissolution pattern. An efficient separation of BI was performed using a stainless steel Supelcosil LC‐18 column (25 cm × 4.6 mm; 5 µm particle size) preceded by a Sentry guard column. The mobile phase consisted of an 80% aqueous solution (pH 2.5 adjusted with phosphoric acid) containing 20% acetonitrile delivered at a flow rate of 1.5 mL/min. The compound of interest was detected using a photodiode array detector at 190 nm. Under these conditions, the assay run time was 6 min since the retention time of BI was 3.8 ± 0.2 min. The detector response was linear for BI in alkaline solution (r > 0.999) in the range of 0.01–2.00 µg/mL. The detection and the quantification limits for BI were 0.005 and 0.01 µg/mL, respectively. The dissolution data showed RSD% of 3.6–12.7% for all BI determined concentrations. No interferences were observed from the tablet's excipients. The drug content in each tablet ranged from 100 to 102.5%. The dissolution study of BIOTIN® tablets revealed that BI in USP media (pH 1.2) showed no dissolution up to 3 hr. However, a first order release kinetic, with dissolution T50% of 14 ± 1.3 min, was observed in USP media (pH 7.4).