Application of cocrystal technique in the enhancement of solubility of spironolactone in drug release by UV spectrophotometric method.

Abstract

The main aim of the thesis is to enhance the solubility of “Spiranolactone” by formulation of co-crystals and to validate the spiranolactone co-crystals by UV-spectrophotometric method. The design of new multicomponent crystal phases of Spiranolactone with desired physicochemical properties by applying crystal engineering technique. Capability to design new multicomponent crystal structures will depend mostly on supramolecular chemistry. The development of new supramolecular complexes, co-crystal and polymorphs of drugs by crystal engineering is becoming progressively more important as an alternative to salt formation, mainly for neutral or weakly ionisable compounds. Validation of the developed UV method was done as per the ICH guidelines Q2(R1). The validation parameters such as linearity, LOD, LOQ, precision and accuracy were evaluated. Linearity and range of the methods were analysed by preparing calibration curves using different concentrations range of standard Spiranolactone-Succinic acid(10-50µg/ml) at 245nm. The calibration curve was plotted using peak area and concentration of the standard solutions. It was concluded that the perfect linearity was observed between the concentration and peak area and the concentration range from 10-50µg/ml. The results revealed that linear regression equation for spiranolactone-succinic acid was Y=0.006x and co-relation co-efficient (R²) value 0.983. Precision studies were carried out and the mean, standard deviation (SD) were calculated and found to be within the limit. The results revealed that percentage co-efficient of variation(%RSD) was found to be >2%. Accuracy is reported as % recovery of the analysed concentration. The results indicate that the recovery of spiranolactone-saccharin was consistent at all levels and the percentage recovery for spiranolactone-saccharin was in between 40-110%.