ABSTRACT

Trimetazidine hydrochloride [1] (TMZ) is an antianginal drug (BCS Class I) used to treat angina pectoris. A simple, rapid, sensitive and economical RP-HPLC method were developed and validate (ICH M10) for quantification of trimetazidine in human plasma by using internal standard as caffeine. Liquid-Liquid extraction (LLE) method was developed for the optimum extraction of trimetazidine and caffeine from biological matrix. For that, Aliquots (450?L) of plasma were spiked with known amount of trimetazidine and caffeine. The separation was accomplished with the help of column Nucleosil ODS (15cm×4.6 mm, 5?) at 25°C and an Agilent HPLC with control panel software. An isobestic wavelength set at 210 nm on advanced PDA detector and the mobile phase was composed of Methanol: Water: Acetonitrile: Sodium Hept-Sulfonate Buffer (40:60:10:03%, v/v/v/v). The injection volume was 5?L and the flow rate was 1.3 ml/min. According to bioanalytical ICH M10 guidelines, the bioanalytical method was validated and found to be selective and linear (r2 0.997, n = 8) after the method was tested across a linear concentration range of 5.04 - 201.60 ng/ml. The obtained result showed that high precision and accuracy. The recovery of TMZ in human blood plasma was found to be 95.80 % w/v. The developed and validated method by using C18 column as per the ICH guidelines can be utilised for routine preliminary pharmacokinetic investigation as well as therapeutic medication monitoring. Keywords: Trimetazidine Hydrochloride, Caffeine, LLE, human plasma, RP-HPLC
Publication date: 01/04/2024

https://ijbpas.com/pdf/2024/April/MS_IJBPAS_2024_7766.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.4.7766