Development and Validation of Stability-Indicating RP-HPLC Method for Estimation of Alogliptin and Linagliptin

Abstract

Symptoms of high blood sugar with complain of frequent urination, increased thirst and increased hunger. The ability to control this quality depends upon the capability of the designed analytical method, as applied under distinct circumstances and at an established required level of detectability, to demonstrate all deviation from acceptance criteria. Drug samples of Alogliptin (AGP) and Linagliptin (LIN) were purchased for Gitar Laboratories, Ahmedabad. Results of force degradation studies, undertaken according to the International Conference on Harmonization (ICH) guidelines, reveal that the method is selective and stability indicating. The stability-indicating RP-HPLC method developed meets the system suitability criteria and resolution of the parent drugs from its degraded products. Detection and quantification limits achieved, describe the sensitivity of developed method. High recovery and acceptable % RSD values confirms that the established RP-HPLC method is accurate and precise.