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Authors
Affiliations
1 Analytical Department, Vishnu Chemicals Limited, Hyderabad, IN
2 Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy Mount Pleasant, Road # 3, Banjara Hills, Hyderabad-500 034, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 2, No 4 (2012), Pagination: 110-113
Abstract
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.
Keywords
Sapropterin Dihydrochloride, RP-HPLC and Tablets.
