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- W2185457253 abstract "The aim of this study was to develop and validate a dissolution test for the quality control of candesartan cilexetil tablets, labeled as containing 8 mg of active pharmaceutical ingredient (API) , using an reverse phase ‐ high performance liquid chromatography (RP-HPLC) method. After the determination of solubility, the conditions selected were paddle at 100 rpm, with 1000 ml of 1 % sodium lauryl sulphate (SLS) in water, pH adjusted to 6.8 with 3N hydrochloric acid at 37°C ± 0.5°C. Under these conditions, the in vitro release profiles of candesartan cilexetil uncoated 8 mg tablets shown good results. The drug release was evaluated by reverse phase ‐ high performance liquid chromatography method using 0.02M mono potassium phosphate: acetonitrile: triethylamine in the ratio of 40:60:02 and adjusted pH to 6 with phosphoric acid at flow rate of 1 ml/min. The method was validated for specificity, linearity, accuracy, precision and solution stability as per ICH guidelines to meet requirements for a global regulatory filing." @default.
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- W2185457253 date "2011-01-01" @default.
- W2185457253 modified "2023-09-29" @default.
- W2185457253 title "Development and validation of a dissolution test for Candesartan cilexetil in tablet forms using reverse phase - High performance liquid chromatography" @default.
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