Formulation of sustained release dosage form of simvastatin and ezetimibe and analytical development by reversed phase high performance liquid chromatography (RP-HPLC)

Authors

  • Ayesha Begum K Bharat Institutute of Engineering and Technology, Mangalpally, Ibrahimpatanam, Hyderabad,
  • Pavani Kasu Bharat Institutute of Engineering and Technology, Mangalpally, Ibrahimpatanam, Hyderabad,
  • Sunitha M Bharat Institutute of Engineering and Technology, Mangalpally, Ibrahimpatanam, Hyderabad, Telangana 501510

Keywords:

Ezetimibe, Simvastatin, Sustained release dosage forms, Reversed phase high performance liquid chromatography, Limit of detection and limit of quantitation

Abstract

The present investigation relates to a process of preparing sustained release dosage forms containing simvastatin and ezetimibe in combination and assay by RP-HPLC method development and validation. Chromatographic separation was achieved on a Water’s Xterra column (250 x 4.6, 5 microns) using a mobile phase consisting of Potassium di hydrogen phosphate and methanol in the rat io of 70:30 at a flow rate of 0.8 ml per minute. The detection was made at 236 nm. The retention time of ezetimibe and simvastatin were 2.6 and 3.4 minutes respectively. The proposed method was validated for Accuracy, Specificity, Precision, linearity, Robustn ess, Limit of Detection (LOD) and Limit of Quantitation (LOQ) were studied as per the ICH guidelines.

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Published

2021-11-08

Issue

Vol. 1 No. 1 (2015): Vol 1, No. 1 (2015) 2015 Volume - 1 Issue-1

Section

Articles

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