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Asian Journal of Pharmaceutical Analysis
ISSN: 2231-5675(Online), 2231-5667(Print)
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The Estimation of Sapropterin Dihydrochloride in Tablet dosage form by RP-HPLC.
P. Janaki Pathi
N. Appala Raju
P. Janaki Pathi1*, N. Appala Raju2 and G.Parvathalu1
1Analytical Department, Vishnu Chemicals Limited, Hyderabad.
2Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy Mount Pleasant, Road # 3, Banjara Hills, Hyderabad-500 034.
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.
Sapropterin Dihydrochloride, RP-HPLC and Tablets.
P. Janaki Pathi, N. Appala Raju, G.Parvathalu. The Estimation of Sapropterin Dihydrochloride in Tablet dosage form by RP-HPLC. Asian J. Pharm. Ana. 2(4): Oct. - Dec. 2012; Page 110-113.
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