Development and validation of a stability-indicating LC-UV method for rapid analysis of buspirone in pharmaceutical dosage forms

Summary An accurate, sensitive, precise, rapid and isocratic reversed-phase HPLC (RPHPLC) method for analysis of buspirone in the bulk drug and in solid dosage formulations has been developed and validated. The best separation was achieved on a 250 mm × 4.6 mm i.d., 5-μm particle, RP C18 column with 70:30 (υ/υ) methanol-0.01 m sodium dihydrogen phosphate buffer (pH 3.5) as mobile phase at a flow rate of 0.8 mL min−1. UV detection was at 244 nm. Response was a linear function of concentration over the range 0.05–20 μg mL−1 (r = 0.9998) and the limits of detection and quantitation were 3.7 and 11.3 ng mL−1, respectively. The method was validated in accordance with ICH guidelines. The drug was subjected to oxidative, hydrolytic, photolytic, and thermal stress. Degradation products produced as a result of this stress did not interfere with detection of buspirone and the assay can thus be regarded as stability-indicating. The method was used for quantification of buspirone in commercial buspirone tablets and t...