DEVELOPMENT AND VALIDATION AND STABILITY STUDY OF A NEW ANALYTICAL RP-HPLC METHOD FOR THE ESTIMATION OF ANTI-DIABETIC DRUG SEMAGLUTIDE IN API FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM

ABSTRACT An efficient and simple RP-HPLC method has been developed and validated for the estimation of Semaglutide in bulk and marketed pharmaceutical dosage forms. The mobile phase used for the chromatographic runs consisted of Methanol and Phosphate buffer (0.02M, pH-3.6)in the ratio of 40:76% v/v. The separation was achieved on anInertsil C18 ODS (4.6mm×250mm) 5µm particle size column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 246 nm. The method was linear at the concentration range 6–14 μg/ml for Semaglutide. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Semaglutide limit of detection (LOD) and limit of quantification (LOQ) were 0.487μg/ml and 1.477μg/ml respectively. Key Words:Semaglutide, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.