Abstract

“DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHODS FOR ESTMATION OF VALSARTAN AND ITS DEGRADATION PRODUCTS”

Piyush N. Kothari*, Pooja Jamode, Dr. Aashish Gawai and Dr. Kailash Biyani

ABSTRACT

A simple, rapid, economic, sensitive and precise RP-HPLC method has been developed and validated for estimation of valsartan and its degradation product. The method was carried out using the gradient programmer and mobile phase was used Methanol and Water (85:15v/v), at a flow rate of 0.7ml/min, on HPLC system containing UV- visible detector with was carried out at 249 nm. The method gave the good resolution and suitable retention time. The method was validated in terms of specificity, linearity, precision, accuracy, specificity, limit of detection, limit of quantitation and robustness. Linearity of Valsartan was found to be 0.9996 in the range of 10 to 50μg/ml. The LOD and LOQ was found to be 0.6442μg/ml and 1.9522μg/ml. The method was also applied for the determination of Valsartan in the presence of their degradation products formed under variety of stress conditions, like acidic hydrolysis, basic hydrolysis, oxidation, photo and thermal degradation. The method was found to be suitable for the quality control of valsartan in bulk and pharmaceutical dosage forms as well as the stability-indicating studies.

Keywords: Valsartan, RP-HPLC, Method Development, Stress Testing, Validation.