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Vol. 7, Issue 5 (2018)

Stability indicating RP-HPLC method development and validation for estimation of Sofosbuvir in pharmaceutical dosage form

Author(s):
KV Lalitha, J Raveendra Reddy and N Devanna
Abstract:
A simple, sensitive, precise and specific Stability indicating high performance liquid chromatography method was developed and validated for the determination of Sofosbuvir. The separation was carried out by using a mobile phase consisting of 0.1% OPA: Acetonitrile (30:70). The column used was symmetry, C18 4.6x250mm, 5µm, with a flow rate of 1.5 ml/min using UV detection at 260 nm. The retention time of Sofosbuvir was found to be 2.37 min respectively. A forced degradation study of Sofosbuvir was conducted under the condition of hydrolysis, oxidation, thermal and photolysis. The detector response of Sofosbuvir is directly proportional to concentration ranging from 100 to 500 mcg/ml. Results of analysis were validated statistically and by recovery studies (mean recovery =100.4). The result of the study showed that the proposed method is simple, rapid, precise and accurate.
Pages: 656-662  |  915 Views  310 Downloads


The Pharma Innovation Journal
How to cite this article:
KV Lalitha, J Raveendra Reddy, N Devanna. Stability indicating RP-HPLC method development and validation for estimation of Sofosbuvir in pharmaceutical dosage form. Pharma Innovation 2018;7(5):656-662.

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