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  3. REVIEW ON STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FIMASARTAN IN BULK AND DOSAGE FORM.
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Lahu D.Tandale , Lahu D.Tandale , Lahu D.Tandale , Lahu D.Tandale

REVIEW ON STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FIMASARTAN IN BULK AND DOSAGE FORM.

The present work was developed on stability indicating methods and validated by using reverse phase high performance liquid chromatography using by bulk and pharmaceutical dosage form. The food and drug administration of korea was approved fimasartan in 2010.The method was developed by using Shimadzu LC prominence-I 2030 model with software of chromeleone. In this method C18 column (150mm x 4.6mm, 5μm particle size) is use with a flow rate of 0.8 ml/min and retention time is 2.4 min. The mobile phase is used cetonitrile(0.1%):Orthophosphoric acid(80:20v/v) and uv detector is used. The 265 nm wavelength was used for detection. The stress condition of fimasartan is checked by performing a different chemical stability test like a Acid degradation, oxidative degradation, alkali degradation and photolytic degradation. This developed method was validated as per ICH guidelines and found to be precise, accurate and specific. The different peak showing by standard drug and dosage form was compared with each other hence this method is used for to check quality of this drug. The wide range of accuracy, precision, linearity, retention time, sensitivity and mobile phase suitable to find out impurities in bulk and pharmaceutical dosage form. The LOD was found to be 1.3 μg/ml.The concentration range of linearity is to be 5-30 μg/ml.