Asian Journal of Pharmacy and Technology

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RP-HPLC Method Development and Validation for Estimation of Sofosbuvir in Pure and Tablet Dosage Form


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1 Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
     

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A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validation of Sofosbuvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6×150mm, 5μ) column using a mixture of Methanol (100% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 265 nm. The retention time of the Sofosbuvir was 3.515 ±0.02min. The method produce linear responses in the concentration range of 20-100μg/mL of Sofosbuvir. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords

Sofosbuvir, RP-HPLC, Validation, Tablet Dosage Forms.
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  • RP-HPLC Method Development and Validation for Estimation of Sofosbuvir in Pure and Tablet Dosage Form

Abstract Views: 247  |  PDF Views: 0

Authors

P. Swathi
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
K. Rajeswar Dutt
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
K. N. V. Rao
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
M. Alagar Raja
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India

Abstract


A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validation of Sofosbuvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6×150mm, 5μ) column using a mixture of Methanol (100% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 265 nm. The retention time of the Sofosbuvir was 3.515 ±0.02min. The method produce linear responses in the concentration range of 20-100μg/mL of Sofosbuvir. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords


Sofosbuvir, RP-HPLC, Validation, Tablet Dosage Forms.

References