Method Development and Validation for Quantif...

Method Development and Validation for Quantification Of N, N-Dimethylformamide In Telmisartan Drugs Substance By Reverse Phase HPLC Using UV Detector

Author Name : Hari Darshan Singh, Dr. Rahul Kumar, Harendra Singh, Rahul Dev, Dr. Anil Kumar

ABSTRACT

A reverse phase HPLC method was developed for quantification of N, N-Dimethylformamide in Telmisartan drugs substance using column Inertsil ODS-3V C18, 250mm length, 4.6mm internal diameter and particle size of 5.0 micron (Make: GL Sciences).  Mobile phase is 1M Potassium dihydrogen phosphate of pH 3.0 in Solution A and HPLC grade Methanol in Solution B with gradient, at flow rate of 1.0 ml/.  The column oven temperature was 250C and wavelength of UV detector was 225nm. The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ determination, Recovery, Precision, Range and Robustness. All the parameters were found within the acceptable limits. Linearity of N, N-Dimethylformamide was in the range of 88.0ppm -1320ppm. HPLC method was specific, accurate, precise and suitable for the analysis of N, N-Dimethylformamide in Telmisartan.

Keywords: Reverse Phase (RP), High Performance Liquid chromatography (HPLC), Guideline for Residual Solvents Q3C(R8) and Method Validation, N, N-Dimethylformamide, Telmisartan drug substance.