Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF IRBESARTAN IN BULK AND TABLET DOSAGE FORM

Yogeesh C. S.*, Sowmya H. G. and Jose Gnana Babu C.

Abstract

A simple, sensitive, precise and accurate HPLC method has been developed and validated for determination of Irbesartan in bulk drug and in pharmaceutical dosage form in the presence of degradation products. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, Phenomenex Gemini 5μ C18 (2) 100A (250 x 4.60mm, 5 μ) column. Hamilton syringe (705 NR, 50 μL) was used for injecting sample and standard solution. Data was compiled using Spinchrom software. Mobile phase consists of mixture of Phosphate buffer: Acetonitrile (70:30 v/v pH 6.0) at a flow rate of 1.0 ml /min. The linear regression analysis data for the calibration curve showed a good linear relationship with regression coefficient 0.9996. The detection was carried out at a wavelength of 224nm. Results: The linearity of the method were excellent over range 1-5μg/ml, the linear regression equation was Y=74061x + 1333.3. The Irbesartan was subjected to stress conditions of hydrolysis (acid, base), photolysis and thermal degradation. Degradation was observed for Irbesartan in acid, base, heat and UV. The degradation products were well resolved from the main peak. The percentage recovery of Irbesartan was from (98.0 to 102.0%.) in the pharmaceutical dosage form. Conclusion: The results demonstrated that the method would have a great value when applied in quality control and stability studies. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, specificity and robustness according to the ICH guidelines. The forced degradation studies prove the stability indicating power of the method.

Keywords: Irbesartan, HPLC, phosphate buffer: Acetonitrile (70:30), ICH guidelines and forced degradation studies.