Analytical method development and validation for impurity profile of antiviral drugs in tablet dosage form

Abstract

quotBackground: newlineThe major problem faced in the pharmaceutical industry today is the newlineestimation of new drugs in combined bulk and dosage forms without any newlineinterference for impurities. Anti-viral drugs are widely used in very common life newlinestyle disorders prevalent globally. The present work describes simple, Specific, newlineprecise, accurate and robust analytical method for related substances of antiviral newlinedrugs by RP-HPLC Method and validate as per ICH Q2 (R1) Guidelines. newlineAim: newlineTo Develop simple, precise, accurate, robust and rapid method for newlineimpurity profile of Antiviral drugs such as Sofosbuvir, Tenofovir alafenamide and newlineValacyclovir hydrochloride in tablet dosage form by RP-HPLC method and newlinevalidate as per ICH Guidelines. newlineMaterials and Methods: newlineIn this newly developed method, chromatographic separation of newlineSofosbuvir and its impurities was achieved on a Kromasil 100 C18 (250 mm x newline4.6 mm, 5 and#956;) column. A sofosbuvir and its impurities were extracted by newlinecomposed mixture of Mobile Phase A: buffer solution: acetonitrile (97.5:2.5 newline%v/v) and Mobile Phase B: acetonitrile, isopropyl alcohol, methanol and purified newlinewater (60:20:10:10 %v/v/v/v) using with flow rate was 1 mL/min, column newlinetemperature was 25ºC, injection volume was 10 and#956;L, Vial thermostat newlinetemperature was 10ºC. The UV detection was carried out at 263 nm. newlineThe chromatographic separation of Tenofovir alafenamide and its newlineimpurities was achieved on an Inertsil ODS-3V (250 mm x 4.6 mm, 5 and#956;) column. newlineThe impurities were extracted by a mixture of Mobile Phase A: buffer solution: newlinePurified water: Acetonitrile (20:78:02%v/v/v) and Mobile Phase B: Solvent newlineMixture and Purified water (75:25%v/v), The injection volume was 20 and#956;L, the newlinecolumn temperature was 40ºC, the flow rate was 1 mL/min, and the detection newlinewas carried out at 262 nm. newlineThe chromatographic separation of valacyclovir hydrochloride and its newlineimpurities was achieved on Crown Pak (150 mm x 4.0 mm, 5 and#956;) column. The newlineimpurities were extracted by composed mixture of buffer solution: Methanol newline(85:15%v/v), flow rate was 1 ml/min, Column temp