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A Novel Stability Indicating RP-HPLC Method for Determination of Sofosbuvir in Bulk and Tablet Dosage Forms

G. Kumaraswamy , G. Kumaraswamy1 , D. Sudheer Kumar2 , V. Ramya3

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Journal of Pharmaceutical and Medicinal Chemistry 5(1):p 13-17, January-June 2019. | DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.5119.2

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G. Kumaraswamy, D. Sudheer Kumar, V. Ramya. A Novel Stability Indicating RP-HPLC Method for Determination of Sofosbuvir in Bulk and Tablet Dosage Forms. J Pharmaceut Med Chem. 2019;5(1):13-17.

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Abstract

The proposed work was accurate and precise stability indicating RP-HPLC method has been developed and validation of Sofosbuvir, in tablet dosage form. The separation was achieved on a Kromasil C18 (4.6×250 mm, 5µ) column using a mixture of Methanol: water (60: 40% v/v) as the mobile phase at a flow rate of 1.0 mL/min and detected 247 nm. The retention time of sofosbuvir 3.475 minutes. The linear responses in the concentration range of 10-60 µg/mL of Sofosbuvir. The method precision for the determination of assay was less than 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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G. Kumaraswamy, D. Sudheer Kumar, V. Ramya. A Novel Stability Indicating RP-HPLC Method for Determination of Sofosbuvir in Bulk and Tablet Dosage Forms. J Pharmaceut Med Chem. 2019;5(1):13-17.

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DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.5119.2

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