Method development and validation of combination of sofosbuvir and velpatasvir by RP-HPLC method

Authors

  • Shirisha Bhavani Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • A. Srinivasa Rao Department of Pharmacy Practice, Bhaskar Pharmacy College, Yenkapally, Moinabad(M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • A. Kavitha Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • B. Haritha Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • Burchu Mary Sunitha Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • Kandi Kanti Manisha Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • N. Swetha Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA

DOI:

https://doi.org/10.61096/ijpar.v8.iss3.2019.358-361

Keywords:

Sofosbuvir and Velpatasvir, HPLC, Method Development, ICH, Validation, Accuracy, Precision

Abstract

Objective

The objective of the present research work was to develop a innovative, simple, and economic method for estimation of Sofosbuvir and Velpatasvir in bulk and dosage form by RP-HPLC.

Methods

The chromatographic conditions were performed on Develosil ODS HG-5 RP C18, 5mm, 15cmx4.6mm i.d. as stationary phase and mobile phase was prepared with a mixture of Potassium Dihydrogen Phosphate buffer (adjusted with 1% Orthophosphoric acid, pH- 3.5) (0.05M) : Acetonitrile with (70:30 v/v), flow 1.0 ml/min, with Injection Volume 10µl, at detection wavelength 257 nm and run time at 10.0 mins

Results

The analytical method is valid for estimation of Sofosbuvir and Velpatasvir over a range of 6 µg/ml – 14 µg/ml and 12 µg/ml – 28 µg/ml. The results of system suitability test, linearity, precision and accuracy, robustness, specificity, LOD and LOQ and stabilities presented in this report are within the acceptance range.

Conclusion

A specific, sensitive, economic method estimation of Sofosbuvir and Velpatasvir has been developed based on ICH Guidelines with bulk and dosage forms.

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Published

2022-09-12

How to Cite

Shirisha Bhavani, A. Srinivasa Rao, A. Kavitha, B. Haritha, Burchu Mary Sunitha, Kandi Kanti Manisha, & N. Swetha. (2022). Method development and validation of combination of sofosbuvir and velpatasvir by RP-HPLC method. IJPAR JOURNAL, 8(3), 347–357. https://doi.org/10.61096/ijpar.v8.iss3.2019.358-361

Issue

Vol. 8 No. 3 (2019): 2019 Volume - 8 Issue - 3

Section

Articles