Separation and Validation of Comprehensive Impurities in Erythromycin Tablets by using Rp-HPLC method

Abstract

In this study a simple, rapid, accurate and precise gradientRP-HPLC method has been developed and validated for the separation of impurities (IMP) in Erythromycin (ERT-A) tablets pharmaceutical dosage form. The chromatographic separation was carried out on WatersX-Terra RP 18 (250 mm x 4.6 mm I.D., 3.5 µm particle size) at 65°C was used for this separation. Mobile Phase-A consists of Buffersolution (35 g of di-potassium hydrogen phosphate in 1000mL of water, adjust the pH7.0with dilute o-phosphoric acid, filtered through 0.45 µm membrane filter) acetonitrile and water in ratio of 5:35:60 v/v/v respectively. Mobile Phase-B consists of a mixture of phosphate buffer pH 7.0, water and acetonitrile in ratio of 5:45:50 v/v/v respectively .The flow rate and injection volume was 1.0 mL/min and 100 μL respectively. The analysis was carried out under the gradient conditions as time (min)/A (v/v): B(v/v); T0/100:00, T45/100:00, T47/0:100, T63/0:100, T65/100:00, and T70/100:00. The wavelength was identified at 215 nm. The ERT-Adegrades under various circumstances. The degradation products were well resolved from the ERT peaks. This method was found to be linear.  The cumulative %RSD values are ;identified and found that they are within the range.  From the study concluded that the method is accurate, specific, selective, precise, robust, and useful during the process development and quality check in finished dosage form manufacturing.