Stability-Indicating UV-HPLC Approaches to Estimate Trimetazidine Dihydrochloride in Extended Release Capsule Formulations

The process of developing a newer or modified method for assessing active pharmaceutical components in dosage forms for extended release capsules and in bulk is known as analytical method development. The evaluation of Trimetazidine Dihydrochloride by utilising the approaches of UV-HPLC was carried out in this study. The optimised setting for the techniques include the linearity lying between 80-400 μg/ml and 4-20 μg/ml for RP-HPLC accordingly. The methods showcased excellent linearity with correlation coefficient noted to be 0.9995 and 0.9999 for the methods of UV and HPLC respectively. The chromatographic conditions employed were the use of JASCO-Extrema LC-4000 System. Methanol was opted as diluent with mobile phase being Acetonitrile: Methanol contained in a ratio of 90:10 v/v and setting a flow rate of 0.8 ml/minute. The column utilised in the process was HiQ SiL C18(250mm x4.6mm, 5μ) thereby having an injection volume of 30μl. For the evaluation activities UV detector was employed with wavelength of 270nm for UV analysis by double distilled water as solvent. PDA detector was employed for chromatographic assessment with PDA detector. In order to determine the stability-indicating nature of the approach under different settings, such as acid, basic, neutral, oxidation, photolysis, and heat environments, forced degradation tests were carried out. This method can be used for normal examination of trimetazidine in capsules because it did not involve any degradation products that would have compromised the product's stability.