Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPLC METHOD FOR ANALYSIS OF TRANYLCYPROMINE IN BULK DRUG AND TABLET FORMULATIONS

Viplav Wagh*, Tushar Borate, Pratik Bhokare and Rahul Tangade

ABSTRACT

Tranylcypromine is a monoamine oxidase inhibitor. The UV method was employed absorption maxima method having absorbance measurement at 265nm. The response of the drug was linear in the concentration range of 80-480μg/ml (r2=0.9999). To establish stability indicating assay method, the separations were achieved on HiQ sil C18 Column (250 mm x 4.6 mm id, 5 μm) using isocratic elution for HPLC analysis. The mobile phase which was optimized consisted of Acetonitrile: Methanol: Water (45: 35: 20 v/v/v) pH adjusted to 2 with ortho phosphoric acid at flow rate 1.0 ml/min at 265 nm. Retention time was found to be 1.98 min for Tranylcypromine. Linearity was observed in the concentration range of 10-60μg/ml (r2=0.9992). The percentage assay of Tranylcypromine was 99.64%. The percentage recovery of drug was found to be 99.79%, 100.38%, 99.81% at recovery level 80, 100, 120 respectively. The drug Tranylcypromine was subjected to different stress conditions, viz hydrolytic, oxidative, photolytic and dry heat as prescribed by ICH. The method distinctly separates the drug from its degradation products within 1.98 min and total run time of 10 min. The methods were successfully validated as per ICH guidelines in terms of accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and forced degradation studies.

Keywords: Tranylcypromine, RP-HPLC, Stability indicating, Validation.