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  • Development And Validation of New RP HPLC Method For the Simultaneous Estimation of Sofosbuvir And Velpatasvir In Combined Pharmaceutical Dosage Form
  • 1Hindu College of Pharmacy, Amaravathi Road, Guntur – 522002, A.P., India
    2University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, A.P., India

Abstract

A simple, rapid, accurate, precise, specific and sensitive reverse phase-HPLC method has been developed and validated for the simultaneous estimation of Sofosbuvir and Velpatasvir in bulk and pharmaceutical dosage form. The chromatographic separation was performed on the Discovery C18 column (250mm×4.6mm, 5?m particle size), using a mobile phase of OPA (0.1%): Acetonitrile = 50:50 (v/v), at a flow rate of 1.0 ml/min in an ambient temperature of 25?C with the detection wavelength of 260nm. The retention times of Sofosbuvir and Velpatasvir were 2.47 min and 3.32 min respectively. The linearity was performed in the concentration range of 100-600 µg/mL, 25-150?µg/mL each of Sofosbuvir and Velpatasvir with a correlation coefficient of 0.998 and 0.999 for Sofosbuvir and Velpatasvir respectively. The proposed method has been validated for specificity, linearity, range, accuracy, precision and robustness were within the acceptance limit according to ICH guidelines and the developed method can be employed for routine quality control analysis in the bulk and combined pharmaceutical dosage form.

Keywords

Sofosbuvir, Velpatasvir, RP-HPLC, ICH

Reference

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Photo
P. Seetharamaiah
Corresponding author

Hindu College of Pharmacy, Amaravathi Road, Guntur – 522002, A.P., India

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Nagaraju Pappula
Co-author

Hindu College of Pharmacy, Amaravathi Road, Guntur – 522002, A.P., India

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JVLN. Seshagiri Rao
Co-author

University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, A.P., India

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D. Gowrisankar
Co-author

University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, A.P., India

P. Seetharamaiah*, Nagaraju Pappula, JVLN. Seshagiri Rao and D. Gowrisankar, Development And Validation of New RP-HPLC Method For the Simultaneous Estimation of Sofosbuvir And Velpatasvir In Combined Pharmaceutical Dosage Form, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 7, 220-229. https://doi.org/10.5281/zenodo.8138641

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