Determination of Buspirone HCl in Commercial Dosage Forms by Extractive Spectrophotometric Method and Comparison by HPLC Method

摘要

An extractive spectrophotometric method has been developed for the determination of buspirone HCl in tablets. It was based on the ion-pair complex formation between buspirone and bromothymol blue in presence of disodium hydrogen phosphate and citric acid buffer solution of pH 4.0 which is extractable in chloroform. The extracted complex showed maximum absorbance at 412 nm. Beer’s law was obeyed in the concentration range of 1.25-30 μg mlsup-1/sup. Various factors affecting the reaction conditions were carefully studied and optimized. Validation parameters based on the guidelines of International Conference on Harmonisation, USA were followed. Effect of common excipients used as additives has been tested and the tolerance limit was calculated for the determination of buspirone HCl. Limits of detection and quantitation were 0.165 and 0.499 ?g mlsup-1/sup, respectively. Proposed method has been successfully applied for the determination of buspirone HCl in pharmaceutical formulations. High performance liquid chromatographic method was employed using 250 mm × 4.6 mm i.d., 5-?m particle, reversed phase C18 column with 70:30 (v/v) methanol-0.01M NaHsub2/subPOsub4/sub buffer as a mobile phase at a flow rate of 0.8 ml minsup-1/sup and UV detection at 240 nm for best separation of buspirone. Results obtained by the proposed method were statistically compared with the HPLC reference method using t- and F- values and found no significant difference between the two methods. The proposed method can be used as an alternate method for routine quality control analysis of buspirone HCl in pharmaceutical formulations.