A dissolution method with robust high performance liquid chromatographic （HPLC） analysis for im- mediate release tablet formulation was developed and validated to meet the requirement as per Inter- national Conferen...A dissolution method with robust high performance liquid chromatographic （HPLC） analysis for im- mediate release tablet formulation was developed and validated to meet the requirement as per Inter- national Conference on Harmonization （ICH） and United States Food and Drug Administration （USFDA） guidelines. The method involved the use of Agilent ZORBAX Eclipse XDB C18 column, and temperature was maintained at 30 ℃. After optimization, the mobile phase was selected as phosphate buffer （KH2PO4, 30 mM） ： ACN （60：40, v/v） with pH 3.0, and retention time Rt was found as 3.24, 4.16, and 2.55 min for paracetamol （PCM）, chlorpheniramine maleate （CPM） and phenylephrine hydrochloride （PH） respec- tively at 265 nm and at a flow rate of 1 mL/min. The relative standard deviation （%RSD） for 6 replicate measurements was found to be less than 2%. Furthermore net analyte signal standard addition method （NASSAM） with spectrophotometer was performed for standard and liquid oral suspension. On the basis of selectivity, sensitivity and accuracy analysis, it was confirmed that this novel method could be useful for simultaneous estimation of the given drug combinations. Two-way analysis of variance （ANOVA） was applied for evaluating the statistical difference between the assay results obtained via both NASSAM and RP-HPLC methods and ultimately no significant difference was found between both the methods. All the methods and results were acceptable and confirmed that the method was suitable for intended use.展开更多
文摘A dissolution method with robust high performance liquid chromatographic （HPLC） analysis for im- mediate release tablet formulation was developed and validated to meet the requirement as per Inter- national Conference on Harmonization （ICH） and United States Food and Drug Administration （USFDA） guidelines. The method involved the use of Agilent ZORBAX Eclipse XDB C18 column, and temperature was maintained at 30 ℃. After optimization, the mobile phase was selected as phosphate buffer （KH2PO4, 30 mM） ： ACN （60：40, v/v） with pH 3.0, and retention time Rt was found as 3.24, 4.16, and 2.55 min for paracetamol （PCM）, chlorpheniramine maleate （CPM） and phenylephrine hydrochloride （PH） respec- tively at 265 nm and at a flow rate of 1 mL/min. The relative standard deviation （%RSD） for 6 replicate measurements was found to be less than 2%. Furthermore net analyte signal standard addition method （NASSAM） with spectrophotometer was performed for standard and liquid oral suspension. On the basis of selectivity, sensitivity and accuracy analysis, it was confirmed that this novel method could be useful for simultaneous estimation of the given drug combinations. Two-way analysis of variance （ANOVA） was applied for evaluating the statistical difference between the assay results obtained via both NASSAM and RP-HPLC methods and ultimately no significant difference was found between both the methods. All the methods and results were acceptable and confirmed that the method was suitable for intended use.
