Navi Mumbai, India
Navi Mumbai, India

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Indumathi K.V.S.,Jawaharlal Nehru Technological University Kakinada | Indumathi K.V.S.,SDS Labs Private Ltd | Someshwara Rao N.,SDS Labs Private Ltd | Rao B.M.,SDS Labs Private Ltd
Research Journal of Pharmaceutical, Biological and Chemical Sciences | Year: 2015

A High Performance Liquid Chromatography (HPLC) method was developed for determination of degradation impurities of Agomelatin drug substance. The chromatographic separation was achieved on Shimadzu LC-2010 with PDA system and C18 150 × 4.6mm, 5.0 μm column using gradient elution of mobile phase. The present study is aim to degrade the drug substance using different degradation conditions like acid, base, oxidative, thermal and light. The degraded products were subjected to LC-MS to find out the impurities mass. Based on the mass of impurities the structures were assigned. The proposed method was successfully employed for identification of Agomelatine impurities in pharmaceutical preparations.


Indumathi K.V.S.,SDS Labs Private Ltd | Someshwara Rao N.,SDS Labs Private Ltd | Rao B.M.,SDS Labs Private Ltd
Research Journal of Pharmaceutical, Biological and Chemical Sciences | Year: 2015

A selective specific and sensitive High Pressure Liquid Chromatography method was developed for determination of Fenoxazoline degradation impurities. The chromatographic separation was achieved on Shimadzu LC-2010 with PDA system and Kromasil C18 column using gradient elution of mobile phase. The present study is aim to degrade the product using different degradation conditions. The degraded products were subjected to LC-MS to find out the impurities. Based on the mass of impurities the structures were assigned. The proposed method was successfully employed for estimation of Fenoxazoline impurities in pharmaceutical preparations.

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