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ABSTRACT:
Two simple, precise, rapid, accurate and economical spectrophotometric methods have been developed for determination of Trimetazidine hydrochloride in bulk and pharmaceutical dosage form. Method A is based on measurement of absorption at 269 nm and method B involves area under curve (AUC) in wavelength range from 264 to 274 nm. The linear responses for both methods were observed in the range of 50-250 µg/ml. The percent assay value and % RSD for assay of TMZ tablet were found within acceptance criteria. The developed methods were successfully validated as per ICH guideline. Percent RSD for Intraday and Inter day precision was found to be 0.490 and 0.670 for Method A and 1.570 and 1.832 for Method B. This study indicates good precision. The accuracy of both methods was assessed by recovery studies and was found within acceptance criteria. Low value of LOD and LOQ indicate the methods are sensitive. Thus the proposed methods can be applied for routine analysis of Trimetazidine hydrochloride.
KEYWORDS: Spectrophotometric method, Area under curve, Trimetazidine hydrochloride, Method validation
1. INTRODUCTION:
Trimetazidine (TMZ) is an effective and well tolerated cytoprotective anti-ischemic agent, which improves myocardial glucose utilization through inhibition of fatty acid metabolism1. The drug is suitable for initial use as monotherapy in patients with angina pectoris and as adjunctive therapy in those with symptoms not sufficiently controlled by nitrates, beta-blockers or calcium antagonists2. It is chemically 1-(2,3,4- trimethoxybenzyl)-piperazine hydrochloride (figure 1)
Literature survey revealed that various UV4,5,6 and HPLC7,8,9,10 methods have been reported for estimation of Trimetazidine HCl. Reported UV methods are expensive as methanol was used as main solvent. In the view to develop an economical methods, proposed work used less quantity of methanol. The objective of this project is to develop simple, accurate and economical and reproducible spectrophotometric methods for estimation of Trimetazidine HCl in bulk and pharmaceutical formulation.
EXPERIMENTAL:
Chemicals and Reagent:
The giftsample of Trimetazine HCl was supplied by M. J. Biopharmaceutical, Mumbai. Methanol AR was obtained from Merck India Ltd. and used as cosolvent. Double distilled water (DDW) was prepared by Easy Still 2000, Infusil India Pvt. Ltd and used as main solvent.
Equipment:
Shimadzu double beam UV-Visible spectrophotometer, model 1800, with a 1 cm quartz cell was used for spectral and absorbance measurement....