Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING UV-VIS SPECTROPHOTOMETRIC ASSAY METHOD OF OLANZAPINE BY USING DIFFERENT STRESS DEGRADATION CONDITIONS

Chandrashekhar Ashok Kale*, Gauri Santosh Kulkarni, Vitthal V. Chopade, Somdatt Y.Chaudhari and P.D.Chaudhari

ABSTRACT

A simple, specific and reliable UV-VIS spectrophotometric method was developed for estimation of Olanzapine in bulk drug and pharmaceutical dosage form. Methanol was chosen as a solvent . The λmax was found to be 258-259 nm and the responses were found to be linear in the range of 2-12μg/ml. The regression equation of the graph and calibration curve were found to be y = 0.079x+0.035 and r2=0.986 respectively. The % RSD values for intraday and interday precision were found to be 1.33 and 1.32 % respectively. The %recovery of the drug ranged from 96.35% and 97.33%. The proposed method was validated for accuracy, precision, ruggedness, robustness, limit of detection, limit of quantitation. Hence this method can be used for routine estimation of Olanzapine in bulk drug and their pharmaceutical dosage forms. The proposed method for stability study showed that there was appreciable degradation found in stress conditions of Olanzapine

Keywords: Olanzapine, Stability study, Degradation.