Development And Method Validation Of An Anti-Viral Drug Sofosbuvir And Its Formulation

Background : For the purpose of measuring sofosbuvir, a number of sensitive, quick, and easy analytical techniques, including RP-HPLC and UV-visible spectrophotometry, have been developed and validated. This study provides comprehensive information on stability, outlining all the scientific steps involved, from choosing the solvent, buffer, and wavelength needed to using appropriate parameters and creating standard solutions. Through experimentation, it was found that a 30:70 ratio of 0.01 M KH2PO4 to acetonitrile pH 3.0 (containing ortho phosphoric acid) was the best mobile phase for analysis. Maximum absorbance was also found at 264 nm in wavelength. Following that, the best analytical development method was verified in accordance with ICH recommendations for linearity, accuracy, precision, and ruggedness, and outstanding results were obtained from all requirements. Result: The results showed that the linearity ranged from 5 to 25 µg mL, the intraday to intraday precision percentage ranged from 0.7477 to 0.8299, and the recovery percentage at 100% accuracy was found to be 0.208%. Conclusion: In conclusion, the approach utilized for analytical development and validation has proven to be very dependable, cost-effective, and repeatable. It has the potential to enhance and improve the quality control division of pharmaceutical companies.