Development and validation for the simultaneous estimation of Sofosbuvir and Ledipasvir by UV spectrophotometer method in bulk and tablet dosage forms

Tabrej Mujawar; Md. Imran; Vinod Bairagi; Kiran Mahajan; Chetan Pulate; Sufiyan Ahmad

doi:10.53730/ijhs.v6nS6.11840

Authors

Tabrej Mujawar Department of Pharmacology, Gangamai College of Pharmacy, Nagaon, Dist. Dhule, Affiliated to Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India
Md. Imran Department of Quality Assurance, K. B. H. S. S. Trust’s Institute of Pharmacy, Malegaon Camp, Nashik - 423105, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India
Vinod Bairagi Department of Pharmacology, K. B. H. S. S. Trust’s Institute of Pharmacy, Malegaon Camp, Nashik - 423105, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India
Kiran Mahajan Department of Pharmaceutics, Sharadchandra Pawar College of Pharmacy, Otur, Tal. Junnar, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India
Chetan Pulate Department of Pharmaceutical Chemistry, Sharadchandra Pawar College of Pharmacy, Otur, Tal. Junnar, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India
Sufiyan Ahmad
sufipharm1712@gmail.com
Department of Quality Assurance, Gangamai College of Pharmacy, Nagaon, Dist. Dhule, Affiliated to Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India

Keywords:

sofosbuvir, ledipasvir, method- development, validation, HPLC

Abstract

The day-by-day new combinations drugs are being introduced in market. Then the multiple therapeutic agents which acts at different sites are used in the management of various diseases and disorders are done. Thus it is necessary to develop methods for analysis with the help of number of analytical techniques which are available for the estimation of the drugs in combination. An accurate, precise and reproducible UV spectrophotometer method was developed for the simultaneous quantitative determination of Sofosbuvir and Ledipasvir in tablet dosage forms. Methods: Younglin (S. K.) gradient system UV detector and C₁₈column with 250 mm x 4.6 mm i. d. and 5μm particle size Acetonitrile: OPA water (80: 20v/v) pH 2.5 was used as the mobile phase for the method. The detection wavelength was 283 nm and flow rate was 0.9 ml/min. Results: In the developed method, the retention time of Sofosbuvir and Ledipasvir were found to be 6.366 min and 8.616 min. The developed method was validated according to the ICH guidelines. Conclusion: In this methods linearity, precision, range, robustness were observed. The method was found to be simple, accurate, precise, economic and reproducible.

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