Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension

The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium

Solubility Prediction of Paracetamol in Water–Ethanol–Propylene Glycol Mixtures at 25 and 30 °C Using Practical Approaches

The solubility of paracetamol in water–ethanol–propylene glycol binary and ternary mixtures at 25 and 30 °C was determined using flask shake method. The generated data extended the solubility database for further computational investigations and also was used to assess the prediction capability of the Jouyban–Acree model. A new version of the model was proposed for modeling the solubility data in water–cosolvent mixtures with the cosolvent concentration of 50% which is required in pharmaceutical formulations. The accuracy of the predicted solubilities was evaluated by the mean percentage deviation (MPD) between the predicted and experimental solubilities. The overall MPD of the Jouyban–Acree model and the log-linear model of Yalkowsky for the entire composition range of the cosolvents were 11.08.7 and 55.417.8%, respectively; the corresponding values for the predicted solubilities in mixtures having a cosolvent concentration of 50% were 12.09.1 and 22.011.0%