The Estimation of Sapropterin Dihydrochloride in Tablet Dosage form by RP-HPLC

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Sapropterin Dihydrochloride in tablet dosage form. An XTerra(R) C18 analytical column (250x4.6 mm, 5 μm particle size) with mobile phase consisting of mixture of buffer 0.02M Ammonium Acetate in water and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 238 nm. The retention time was 2.9 min. The detector response was linear in the concentration of 20-120 mcg/mL. The respective linear regression equation being y= 3234.6x-3233.6. The limit of detection and limit of quantification was 0.01mcg/mL and 0.03mcg/mL respectively. The percentage assay of Sapropterin Dihydrochloride was 99.4%. The method was validated by determining its accuracy, precision and system suitability.

The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Sapropterin Dihydrochloride in bulk drug and in its pharmaceutical dosage form.