Development and Validation of Stability Indic...

Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Evogliptin Tart rate and Metformin Hydrochloride in Tablet Dosage Form

Author Name : Jemin Makadiya, Mr. Dhirendra Kumar Tarai, Dr. Sibaji Sarkar

ABSTRACT

Validation data of three consecutive batches, it shall be concluded that the manufacturing process used for Metformin Hydrochloride and Evogliptin Tartrate consistently produces the product of pre-determined quality parameters. The Process validation showed that there was no significant batch-to-batch variation and all the process variables were studied and it showed consistent and reproducible results.  Therefore, it can be concluded that the process stands validated. Also Considering the efficiency of RP - HPLC, attempt has been made to develop simple, accurate, precise, rapid and economic method for estimation of Metformin Hydrochloride and Evogliptin Tartrate in synthetic mixture. Thus, method described enables to the quantification of Metformin Hydrochloride and Evogliptin Tartrate. The advantage lies in the simplicity of sample preparation and low costs of reagents used. Experimental results were indicative of satisfactory precision and reproducibility. Validation parameters shows method can work in the range. The observation and result obtained for each validation parameter including linearity and range, method precision (repeatability), intermediate precision (ruggedness), specificity, accuracy, solution stability, filter compatibility, filter saturation, robustness, force degradation study and system suitability lie well within acceptance criteria. Hence, this HPLC method can be used for routine analysis of drug from its solid dosage form.