Abstract

NOVEL VALIDATED REVERSE PHASE CHROMATOGRAPHIC METHOD FOR THE STABILITY INDICATING STUDIES OF LORNOXICAM DOSAGE FORM

Kommana Bala Ram Kumar*^a, Girija Sastry.V^b, Preethi Priyadarshini^c

ABSTRACT

The objective of the current study was to develop and validate a rapid, precise, specific and stability-indicating reverse phase HPLC for the quantitative determination of Lornoxicam in its dosage form. The determination is done for the active pharmaceutical ingredient in its pharmaceutical dosage form in the presence of degradation products. The drug was subjected to stress conditions of acid, alkali, thermal, photolytic, humidity and peroxide. As per international conference on harmonization (ICH) prescribed stress conditions to show the stabilityindicating power of the method. It was found lornoxicam is very sensitive to various stress conditions. The chromatographic conditions were optimized using the samples generated from forced degradation studies. Regression analysis shows an r value (correlation coefficient) 0.998 for lornoxicam. The chromatographic separation was achieved on a symmetry C18 stationary phase. The method employed an isocratic elution and the detection wave-length was set at 379 nm. The mobile phases consists of water and methnol delivered at a flow rate of 1.2 mL•min–1. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.

Keywords: Lornoxicam, Forced degradation, Assay, Method Validation, HPLC.