Abstract
Background: A simple, sensitive and precise spectrodensitometric method has been developed and validated for simultaneous determination of sofosbuvir, ribavirin and saxagliptin in their pure and pharmaceutical dosage forms.
Methods: The method employed TLC plates precoated with silica gel G 60 F254 as the stationary phase. The mobile phase consisting of acetonitrile-water (80:20, v/v) was used to give compact bands for all the studied drugs at 228 nm. They were resolved with retardation factor (Rf) values of 0.71, 0.36 and 0.21 for sofosbuvir, ribavirin and saxagliptin respectively.
Results: The linearity ranges were 400 – 10000 ng/band for all the studied drugs. Limits of detection were 124.78, 124.31 and 128.29 and limits of quantitation were 378.13, 376.71, 388.77 ng/band for sofosbuvir, ribavirin and saxagliptin, respectively. Correlation coefficient (r) values were 0.9993, 0.9995 and 0.9991 for sofosbuvir, ribavirin and saxagliptin, respectively.
Conclusion: The method was validated according to ICH guidelines and has been successfully applied for the determination of the studied drugs in their pure and dosage forms without any interference from the commonly encountered excipients.
Keywords: TLC-spectrodensitometry, sofosbuvir, ribavirin, saxagliptin, pharmaceutical preparations, HCV.
Graphical Abstract
15
3