Development and validation of an analytical method by HPLC for simultaneous quantification of betamethasone dipropionate and betamethasone sodium phosphate in injectable suspension

摘要

A reversed-phase HPLC method was developed and validated to separate and simultaneously quantify the association of betamethasone sodium phosphate (BP) and betamethasone dipropionate (BD) in injectable suspensions. Chromatographic conditions were ternary gradient elution at 1.6 mL/min on a C18 column with 254 nm. The linearity of the method was established in the range 120 to 280 mg/mL BD, and 48 to 112 mg/mL BP. The RSD of intermediate precision of the method was 1% and recoveries were 99-101% for both drugs. The method proved selective, linear, precise, accurate and robust for quantifying BP and BD in commercial injectable suspensions.