A VALIDATED STABILITY INDICATING RP-UPLC METHOD FOR DETERMINATION OF ERYTHROMYCIN ESTOLATE IN PHARMACEUTICAL FORMULATION

摘要

A novel, sensitive and selective stability-representing RP-UPLC method was developed and validated for the quantitative determination of Erythromycin estolate in Erythromycin 250 mg capsules. The chromatographic separation was achieved on BEH C18; 50 × 2.1 mm; 1.7 μm column by using mobile phase containing a mixture of 0.002M di-potassium hydrogen phosphate and acetonitrile 53:47 v/v at a flow rate of 0.6 ml/min. The column temperature was maintained at 40 °C and detection was carried out at 210 nm. To ascertain the stability-signifying ability of the method, drug product was subjected to strain conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The drug undergoes degradation at oxidative and thermal / humidity stress conditions. The resultant degrading peaks were well resolved from the drug peak. The drug was found to be stable in thermal and photolytic conditions. The proposed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness and the method show excellent linearity and a correlation coefficient of more than 0.99. Therefore, the projected method can be employed for the determination of Erythromycin estolate in various pharmaceutical formulations during regular and quality-control analysis.