Журнал аналитических и биоаналитических методов

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Development and Validation of an HPLC Method for Quantifying Dapiprazole in Bulk Preparations

Jaya Prasanthi K and Syama Sundar B

A simple, precise, rapid and accurate Reverse phase HPLC method was developed for the estimation of Dapiprazole in bulk form. A Thermo hypersil C-18 column (250 mm×4.6 mm 5μm) with mobile phase consisting of mixture of methanol: acetonitrile: and ortho-phosphoric acid in the ratio of 89: 9: 1 (v/v) at pH 5.8 adjusted with ortho-phosphoric acid. The flow rate was 0.8 mL/min and the effluents were monitored at 243 nm. The retention time was 3.725 min. The detector response was linear in the concentration of 20-120 μg/mL. The respective linear regression equation being y=1956.4x+3409. The limit of detection and limit of quantification was 0.5 μg/mL and 1.6 μg/mL respectively. The percentage assay of Dapiprazole was 99.94%. This method has been validated and shown to be specific, sensitive, precise, linear, accurate, rugged, robust and fast. Hence, this method can be useful for the routine determination of Dapiprazole in bulk drug and in its pharmaceutical dosage form.