ABSTRACT

A simple, precise, accurate method was developed for the estimation of Ritonavir by RP-HPLC technique. Chromatographic conditions used are stationary phase Ascentis C18 150mm x 4.6 mm, 2.7? , Mobile phase Acetonitrile: NaH2PO4 in the ratio of 60:40. Then pH adjusted to 4 with orthophosphoric acidand flow rate was maintained at 1ml/min, detection wave length was 239 nm, column temperature was set to 30?C and diluent was mobile phase. Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.3 for repeatability and 0.7 for intermediate precision. LOD and LOQ are 0.54?g/ml and 1.65?g/ml respectively. By using above method assay of marketed formulation was carried out 99.49% was present. Degradation studies of Ritonavir were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Keywords: Degradation; HPLC; ICH Guidelines; Ritonavir; Validation parameters
Publication date: 01/05/2020

https://ijbpas.com/pdf/2020/May/MS_IJBPAS_2020_5054.pdf

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https://doi.org/10.31032/IJBPAS/2020/9.5.5054