Development and Validation of Stability Indicating HPTLC Method for Determination of Trandolapril as Bulk Drug

Trandolapril is a drug in current clinical practice as antihypertensive. It modulates the renin-angiotensin-aldosterone system that plays a major part in regulating blood pressure. The present study describes degradation of Trandolapril under different ICH prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat and photolysis) and establishment of a stability-indicating HPTLC assay method. Though a separate peak for the products of degradation was not obtained, the peak purity of the drug was observed. For HPTLC Silica Gel 60 F₂₅₄ plate and mobile phase consisting of ethyl methyl ketone : acetic acid (8 : 0.25) was used to achieve separation and quantitation was done at 220 nm. The method was found to be simple, specific, precise, and stability indicating.