Abstract
In the present study a simple, sensitive rapid and accurate HPLC method with UV detection for the analysis of cinitapride hydrogen tartarate was developed and validated in solid dosage forms. The method utilized gradient elution technique with C18 column (150×4.6 mm I.D, 5 μm particle size) with mobile phase consisting of 0.1% formic acid in water and acetonitrile The detection wavelength was at 268 nm, with flow rate of 0.5 mL/min and injection volume of 10 μL for separation of cinitapride in bulk drugs and pharmaceutical formulations. The gradient elution was developed for better and optimized results. The developed method was validated for precision which includes system precision and method precision, accuracy and linearity studies in the concentration range of 5-100 μg/mL with correlation coefficient of 0.9987. The accuracy (recovery) was between 97.32 and 100.82%. The proposed method is simple, fast, accurate, precise and reproducible, hence can be applied for routine quality control analysis of cinitapride in pure and pharmaceutical dosage forms.
Highlights
Cinitapride[1,2], chemically 4-amino-N-[3-(Cyclohexan-1-yl-methyl)-4-piperidinyl]-2-ethoxy5-nitrobenzamide has the molecular formula C21H30N4O4 and molecular weight 402.49 g.mol-1
Cinitapride is a drug that has against action to the serotoninergic 5-HT2 and D2 dopaminergic receptors that has been indicated in the gastro-esophageal reflux and in the functional disorders of gastrointestinal motility treatment
Weighed 50 mg of cinitapride standard was taken in 100 mL volumetric flask
Summary
Cinitapride[1,2], chemically 4-amino-N-[3-(Cyclohexan-1-yl-methyl)-4-piperidinyl]-2-ethoxy5-nitrobenzamide has the molecular formula C21H30N4O4 and molecular weight 402.49 g.mol-1. The target of this study was to develop and validate a new, simple and rapid HPLC method with gradient elution technique for determination of cinitapride in bulk drugs and pharmaceutical formulations. The gradient elution programme has been developed and optimized for better, accurate and consistent results. Weighed 50 mg of cinitapride standard was taken in 100 mL volumetric flask. This was dissolved in few mL of methanol and sonicated for five minutes and diluted up to the mark with same solvent to get 500 μg/ mL standard stock solution. Solution obtained was diluted with methanol to obtain in the range of linearity previously for the pure drug determined.
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