Stability Indicating Rp-Hplc Method Development And Impurity Profiling By Forced Degradation Study Of Antiretroviral Drugs

An error-free, accurate, precise and valid reverse-phase liquid chromatography method was developed for the quantitation of valganciclovir and darunavir in its bulk form as well as in dosage form by forced degradation studies. Chromatographic separation of these two drugs valganciclovir and darunavir, was achieved with an chemsil ods-c18 column (250 mm × 4.6 mm, 5 μm) reverse-phase analytical column with a 10 min analytical run time using a mixture of acetonitrile : ortho phosphate buffer of ph 4 (60:40% v/v) as mobile phase. The mobile phase was streamed at a flow rate of 1.0 ml min-1 with a column temperature of 250 °c, and detection wavelength was carried out at 257 nm. Darunavir and valganciclovir showed retention times of 4.1 minutes and 3.1 minutes, respectively. The limit of quantization (loq) for all degradation impurities was found to be 0.05%, matching the reporting threshold. The method demonstrated linearity and accuracy in the range, with accuracy values ranging between 99.2-99.4% and 97.82-99.82% respectively. Precision was confirmed by %rsd below 0.5%, and the method proved to be robust under minor variations. The proposed validation process is very simple as well as more accurate stability -indicating hplc process is developed to routine analysis to both the drugs includes valganciclovir as well as darunavir in bulk and tablet dosage forms. These compounds/substances are subjected to evaluation with forced degradation pertaining to several stress circumstances. This developed process separates both drugs and their products of degradation successfully also quantifies active contents at minute strength levels. This developed method is totally applied considering the rules and regulations given by ich to all parameters those are identified within acceptance criteria