A SIMPLE AND RAPID VALIDATED STABILITY INDICATING HPLC METHOD FOR THE DETERMINATION OF DROSPIRENONE IN A PHARMACEUTICAL PRODUCT

The main objective of the present research work was to develop and validate a simple reversed-phase high performance liquid chromatography (RP-HPLC) stability-indicating method for the determination of synthetic progestin drospirenone. The chromatographic separation was performed by using the instrument Shimadzo Prominance model L20 HPLC system equipped with SPD 20A prominence UV-Vis detector, RESTEX allure C18 (250mm × 4.6mm i.d., 3 μm particle size) column. Isocratic elution was performed using methanol: water (65:35 v/v) as solvent and UV detection at 247 nm. The RP-HPLC method developed for analysis of drospirenone was validated with respect to specificity, selectivity, linearity, accuracy, precision and robustness as per the ICH guidelines. The linearity for developed method was perceived in the concentration range of 3-18 μg/mL with the correlation coefficient of 1.0. The percentage accuracy of drospirenone ranged from 99.06 to 100.62%. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of drospirenone was determined in tablet dosage form was found to be within limits. Drospirenone was subjected to stress conditions such as neutral, acidic, alkaline, oxidation and photolysis degradations as per ICH guidelines. The peaks of degradation products were found to be resolved effectively from the standard drug peak and hence this method can be used for quality control assay of drospirenone. The degradation studies revealed that the drug was found to degrade maximum (74.27%) in alkaline degradation conditions followed by oxidative degradation conditions (36.41). The drug was highly resistant towards neutral, acidic and photolytic degradation conditions.