Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN HEMIHYDRATE HYDROBROMIDE AND ROSUVASTATIN CALCIUM IN SYNTHETIC MIXTURE

Saiyed Javedmiya Mukhtiyarmiya* and Dr. Sibaji Sarkar

ABSTRACT

A HPTLC method has been developed and validated for the simultaneous estimation of rosuvastatin and Teneligliptin hydrobromide hydrate in in bulk drug and synthetic mixture. Good separation of analytes were achieved by using Ethylacetate: Toluene: Acetonitrile: Formic Acid (6:3.5:0.5:0.2 v/v/v/v) with retardation factor (Rf) values of 0.37 ± 0.01 for ROS and 0.76 ± 0.01 for TEN on precoated silica gel 60F 254 plates. ROS and TEN, both were found to undergo alkali hydrolysis. The degradation of rosuvastatin for with additional peaks at Rf values of 0.53 respectively and teneligliptin, additional peaks were observed with R values 0.68 respectively. Rosuvastatin (ROS) and Teneligliptin (TEN), both were found to undergo acid hydrolysis. The acid hydrolysis showed degradation of Rosuvastatin for with additional peaks at Rf values of 0.48 and Teneligliptin, additional peaks were observed with Rf values 0.62. Rosuvastatin (ROS) and Teneligliptin (TEN), both were found to undergo oxidative reaction. In the oxidative degradation study, it was found that both Rosuvastatin (ROS) and Teneligliptin (TEN) were very little to degradation without formation of any additional peak.Rosuvastatin (ROS) and Teneligliptin (TEN), both were subjected to dry heat condition. In the dry heat degradation study, it was found that both drugs are stable and very little degradation occur without formation of additional peak. Photo degradation study showed that Teneligliptin (TEN) were stable in sunlight. Rosuvastatin with additional peaks at Rf values of 0.44 respectively. The proposed validated method was successfully applied to determine rosuvastatin and Teneligliptin hydrobromide hydrate in bulk and synthetic mixture. There is no other co eluting peak with the main peaks, hence the HPTLC method is specific for the estimation of Rosuvastatin and Teneligliptin hydrobromide hydrate. The validated method was found to be accurate, precise, specific and robust.

Keywords: Rosuvastatin, Teneligliptin hydrobromide hydrate, Stability indicating HPTLC.