S. Lakshmana Prabu 1*, N. Sivagurunathan 1, C. Dinesh Kumar 1, S. G. Vasantharaju 1, B. Meenashi Vanathi 2
- Manipal College of Pharmaceutical Sciences, Manipal University, Manipal- 576104, Karnataka, India
- Shree Devi College of Pharmacy, Mangalore, Karnataka, India
Abstract
A simple, rapid and accurate RP-HPLC method was developed for the determination of racecadotril in solid pharmaceutical dosage form. The method showed a linear response for concentrations in the range 10-200 ?g/ml using methanol: water (80:20 v/v) as the mobile phase with detection at 231 nm and a flow rate of 1.2 ml/min. Solution concentrations were measured at a weight basis to avoid the use of an internal standard. The method was statistically validated for accuracy, precision, linearity, range, ruggedness, robustness, forced degradation, solution stability, and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be 0.53. Due to the simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis.
