Development and validation of RP-HPLC method for the determination of Racecadotril in formulation
Journal Title: International Journal of ChemTech Research - Year 2009, Vol 1, Issue 4
Abstract
A simple rapid specific precise and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Racecadotril (RACE) in sachet dosage forms using atorvastatin as internal standard. Ratio of the peak area of analyte to internal standard was used to calculate for quantification. A phenomenex-Luna RP-18, 5mm column having 250x4.6 mm i.d. in isocratic mode, with mobile phase containing acetonitrile: 0.05M phosphate buffer (potassium dihydrogen orthophosphate): triethylemine (80:19.95:0.05) adjusted to pH 3.95 using orthophosphoric acid. The flow rate was 1.0ml/min and effluents were monitored at 231nm. The retention times of atorastatin calcium and racecaclotril were 3.453 min and 4.210 min respectively. Linearity was observed over concentration range of 10-80 mg/ml. The recovery of racecadotril was found to be in the range of 99.6-100.5%. The proposed method was validated successfully and applied to the estimation of a racecadotril in sachet dosage forms.
Authors and Affiliations
Anton Smith A, Madhusudhana Reddy Induri, Varaprasad k, Manavalan R
Keywords
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Development and validation of RP-HPLC method for the determination of Racecadotril in formulation
A simple rapid specific precise and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Racecadotril (RACE) in sachet dosage forms using atorvastatin as internal...