RP-HPLC Method for the Determination of Rosiglitazone in presence of its Degradation Products in Bulk Drugs

This study describes an isocratic RP-LC method that uses a water rich mobile phase for the estimation of rosiglitazone in presence of its degradation products generated from forced decomposition studies. The separation was achieved with a C18 column using mobile phase comprising of water: methanol: ortho phosphoric acid (80: 20: 0.2, v/v), the pH of which was adjusted to 4.5 with the help of liquid ammonia. The flow rate was kept at 1 ml/min and analyte was screened with UV detector at 230 nm. The retention time for rosiglitazone was found to be 4.97 minutes. The drug was found to degrade extensively in oxidative degradation and mild degradation in acidic degradation while it was found stable in alkaline stress. The developed method was precise and sensitive and could be applied successfully to determine rosiglitazone in the presence of its degradation products.

Author(s): Mahendra K. Patil, Ajay S. Raghuwanshi, U. K. Jain, Ajit S. Raghuwanshi, Nilesh Gupta and Ajay Patel

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