Stability Indicating Method Development and Validation of the Trandolapril in Human Plasma by LCMS/MS in Bulk and Tablet Dosage Form

A selective, sensitive and rapid HPLC-MS/MS method has been developed and validated for simultaneous quantification of trandolapril in human plasma using meloxicam as internal standard (IS). The analytes and IS were extracted from 200 L of plasma by liquid-liquid extraction technique. Chromatographic separation was achieved in 5.3 min and run time was 6.5min, on a Zorbax Eclipse XDB-Phenyl 3.5, 7.5 x 4.6 mm using a 0.1 % formic acid and acetonitrile (30/70 V/V) as mobile phase. The quantification of target compounds was performed in a positive electrospray ionization mode and multiple reaction monitoring (MRM). The proposed method was validated over the concentration ranges of 5.061-500.682 pg/ml for each analyte. The intra- and inter-day precision and accuracy results were acceptable as per FDA guidelines. Stability of compounds were established in a battery of stability studies, i. e. bench top, auto sampler, dry extract and long term storage stability as well as freeze-thaw cycles. The validated method has been successfully used to analyze human plasma samples for stability studies under various storage conditions.