S.Sharma1, M.C. Sharma*, A.D. Sharma
Description:
The invitro release of various test units was compared for their similarity using the f2 test which limits were found within the acceptance criteria. All the validation parameters were with in the acceptance range according to ICH norms. The described method was successfully employed for quality control assay of both the component simultaneously and dissolution data helpful in generating the further information regarding absorption rate in tablet dosage form. HPLC was performed with a Shimadzu LC-10 AT VP solvent-delivery system, a Shimadzu SPD-10 AVP UV–visible photodiode-array detector, and a Rheodyne7725 I universal loop injector of injection capacity 20 μL. The equipment was controlled by a PC workstation. Compounds were separated on a 25 cm × 4.6 mm i.d, 5-μm particle, Phenomenex Luna C18 column under reversed-phase partition chromatographic conditions. The mobile phase constituted of Buffer: Acetonitirile with gradient program was delivered at the flow rate 1.0 mL/min. Detection was performed at 271 nm. Separation was completed within 14 min. Gatifloxacin was used as an internal standard. The relative standard deviation (R.S.D) was found to be less than 2.0%.