P. Janaki Pathi, N. Appala Raju
P. Janaki Pathi1*, N. Appala Raju2
1Analytical Department, Vishnu Chemicals Limited, Hyderabad.
2Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy Mount Pleasant, Road # 3,
Banjara Hills, Hyderabad-500 034.
Volume - 2,
Issue - 2,
Year - 2012
A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Epalrestat in tablet dosage form. An XTerra(R) C18 analytical column (250x4.6 mm, 5 µm particle size) with mobile phase consisting of mixture of buffer (0.03M Potassium Dihydrogen phosphate in water at pH 3.2 with ortho-phosphoric acid) and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 294 nm. The retention time was 15.9 min. The detector response was linear in the concentration of 20-120 mcg/mL. The respective linear regression equation being y= 3818.8x-3819. The limit of detection and limit of quantification was 0.005mcg/mL and 0.015mcg/mL respectively. The percentage assay of Epalrestat was 99.3%. The method was validated by determining its accuracy, precision and system suitability.
The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Epalrestat in bulk drug and in its pharmaceutical dosage form.
Cite this article:
P. Janaki Pathi, N. Appala Raju. The Estimation of Epalrestat in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2(2): April-June 2012; Page 49-51.