Development and Validation of Stability-Indicating RP-HPLC Method for Tramadol in Tablet Formulation

Author(s)

Shinde, R., Sonawane, S., Kshirsagar, S., Sonar, A.

Author's Affiliation

Abstract

The present paper describes development of stability-indicating RP-HPLC method for the determination of Tramadol in presence of its degradation products, generated from forced degradation studies. Tramadol was subjected to forced degradation under acidic, basic, hydrolytic, photolytic and oxidative conditions. Successful separation of drug from degradation products formed under forced degradation conditions was achieved on a C18 column using methanol: 0.02 M potassium phosphate buffer (pH 6.8) (80:20 v/v) as a mobile phase at a flow rate of 1ml/ min. The detection was carried out at 272nm. The method was validated for linearity, range, accuracy, precision and selectivity.

Keywords

Forced Degradation Studies, RP-HPLC, Tramadol, Validation

Cite This Article

Shinde, R., Sonawane, S., Kshirsagar, S., Sonar, A. (2015). Development and Validation of Stability-Indicating RP-HPLC Method for Tramadol in Tablet Formulation, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(2), 517-521.