VALIDATED STABILITY-INDICATING RP-HPLC ASSAY METHOD FOR VALGANCICLOVIR HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM ACCORDING TO ICH GUIDELINES

Karthik K.*, Jose Gnana Babu C., and Sowyma H. G.

ABSTRACT

Objective: A simple, sensitive, precise and accurate stability-indicating HPLC method has been developed and validated for determination of Valganciclovir hydrochloride in bulk drug and in pharmaceutical dosage form in the presence of degradation products. Methods: 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 0.01M sodium dihydrogen phosphate buffer (A) and Acetonitrile (B) in the ratio (pH 5.0±0.1, ratio 60:40 v/v) 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 254nm. Results: The linearity of the method were excellent over range 2-12μg/ml, the linear regression equation was Y = 118614x + 7332.9. The Valganciclovir hydrochloride was subjected to stress conditions of hydrolysis (acid, base), photolysis and thermal degradation. Degradation was observed for Valganciclovir hydrochloride in acid, base, heat and UV. The degradation products were well resolved from the main peak. The percentage recovery of Valganciclovir hydrochloride 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: Valganciclovir hydrochloride, HPLC, 0.01M sodium dihydrogen phosphate buffer: Acetonitrile (60:40), ICH guidelines and forced degradation studies.