Development Of a Novel by RP – HPLC Method for The Estimation of Glatiramer Acetate

In the present work, an attempt was made to provide newer, sensitive, simple, accurate and low cost HPLC methods. It is successfully applied for the determination of Glatiramer acetate in pharmaceutical preparations without the interferences of other constituents in the formulations new RP-HPLC method was developed for both bulk drug and formulation. These proposed methods give reliable assay results with short analysis time (<10.0 min) using the mobile phase of (Acetonitrile: Trifluoracetic acid) with 1.0 ml/min flow rate is quite robust. The optimum wavelength for detection was 220 nm at which better detector response for drugs was obtained. The wavelength was found to be 220nm for Glatiramer acetate. The average retention time for Glatiramer acetate was found to be 9.039min respectively. System suitability tests are an integral part of chromatographic method. They are used to verify the reproducibility of the chromatographic system. To ascertain its effectiveness, system suitability tests were carried out on freshly prepared stock solutions. The HPLC calibration was linear in concentration range of 80-120%with regression 1.000 for Glatiramer acetate. The low values of % R.S.D. indicate that method is precise and accurate. The mean recoveries were found in the range of 99.74-100.02 %for HPLC. These results show the accuracy and reproducibility of the assay. Ruggedness of the proposed methods was determined by analysis of aliquots from homogeneous slot by different analysts, using similar operational and environmental conditions; the % R.S.D. reported was found to be less than 2 %. The proposed method was validated and the results of all methods were very close to each other as well as to the label value of commercial pharmaceutical formulation.