Abstract

DEVELOPMENT AND VALIDATION OF HPTLC ANALYTICAL METHOD FOR THE ESTIMATION OF ANTILIPEMIC DRUG AND ITS DOSAGE FORM

Ms. Vaishnavi Sanjay Dhengane*, Prof. Suvarna Sharad Vanjari, Dr. Rajendra B. Patil, Prof. Nilima Choudhary

ABSTRACT

Simvastatin is a HMG-CoA reductase inhibitor, used as anti-lipidemic drug. A sample reproducible, acerated and precise HPTLC analytical method development & validation for estimation of anti-lipemic agent. The chromatographic parameters was performed on TLC aluminium plate precoated with silica gel 60 F254 by using Ethyl acetate: Methanol (6.5:3.5 v/v) as mobile phase. Detection Wavelength 238nm, Saturation time was 15 min and Band width 6mm in HPTLC system. The developed method was validated as er ICH guideline validation parameters like linearity, accuracy, precision, ruggedness & specificity was performed to validate the developed method. Simvastatin was found to be liner in the range of 500-3000ng/band. Accuracy study was performed three level concentration, samples should be 99.632±0.552. The %RSD was found to be 0.773. The LOD and LOQ was found to be 52.147ng/band and 158.022ng/band respectively. It was found that all the validation parameters were found to in the appropriate limit. This method can be used in determination of simvastatin by HPTLC method.

Keywords: Camag HPTLC System, Linomat - 5 sample applicator, Camag TLC Scanner 3, Win CATS software V- 1.4.2, Hamilton syringe (100?l), Starstat 40.