Assay and Dissolution Methods Development and Validation for Simultaneous Determination of Sofosbuvir and Ledipasvir by RP-HPLC Method in Tablet Dosage Forms by Mohamed El-Kassem M Hassouna in JFSCI - Juniper Publishers
Specific, accurate, simple, selective and stability-indicating RP-HPLC method is developed and validated for simultaneous determination of Sofosbuvir and Ledipasvir in tablet dosage form for assay and dissolution methods. RP-HPLC method was performed on the Eclipse XDB C18 column (250 mm X 4.6 mm, 5 μm particle size, using buffer solution of pH 3.0 containing 0.02 M potassium dihydrogen phosphate and 5.7 mM hexane sulfonate:acetonitrile (50:50 v/v) as the mobile phase at a flow rate of 1.5 ml/min, injection volume 10 μL and UV detection at 254 nm. This method is validated according to BP, USP and ICH requirements for new methods, which include accuracy, precision, selectivity, robustness, ruggedness, LOD, LOQ, linearity and range. Linear relationships were obtained in the ranges of 40-500 μg/mL and 30-300 μg/ mL with correlation coefficients of 0.9998, 0.9996, 0.9996 and 0.9993 at RTvalue of 2.429 min and 4.529 min for Sofosbuvir and Ledipasvir respectively for assay content and dissolution rate. The forced degradation studies as acidity, alkalinity, oxidation, heat, thermal, humidity and photo degradation were performed according to ICH guidelines. The accurate determination of both drugs is very important for Forensic and Criminal Investigations from the point of view of Forensic pharmacy.
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