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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 μL 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 3.5μ, 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 intraand 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.

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