Spectrometric and reverse phase high performance liquid chromatographic methods for the determination of certain pharmaceuticals in bulk and dodage forms

Abstract

The present research work aims for the development of various analytical methods like UV, HPLC and HPTLC for the determination of new chemical entities which has been approved recently by USFDA. In the present work five new chemical entities namely Pregabalin, Rasagiline Mesylate, Darifencin Hydrobromide, Doripenem and Tapentadol hydrochloride are selected for analytical method development and validation. The analytical methods were developed by selecting economic solvents. The following sections address the brief experimental information regarding the present research work. newlineA simple, sensitive, specific, UV spectrophotometric method was used to determine the purity of aforementioned drugs in bulk and pharmaceutical formulations. RP-HPLC method of pregabalin was carried out using Inertsil ODS 3V, (250 mm x 4.6 mm, 5and#956;m) column and phosphate buffer (pH adjusted to 5.9): acetonitrile as mobile phase at a flow rate of 1.0 mL/min. A novel, sensitive, stability indicating gradient RP-LC method for quantitative analysis of rasagiline mesylate and its related impurities in API (Active Pharmaceutical Ingredient) as well as its Pharmaceutical preparations was also taken up for the present investigation. Efficient chromatographic separations were achieved on X- bridge C18 stationary phase with a simple mobile phase gradient. The developed LC method may be used to evaluate the quality of pharmaceutical products. Similarly a validated, stability- indicating and novel RP-LC method for the quantitative analysis of darifenacin hydrobromide, Doripenem for injection and Tapentadol hydrochloride was also delved upon using organic mobile phase and reversed phase LC method. newlinexxi newlineNowadays HPTLC is becoming one of the most popular techniques, so the present investigation was also aimed to develop HPTLC method for determining the purity of aforementioned drugs. The HPTLC method was carried on silica gel 60 F254 plates as the stationary phase and different organic mobile phases. The developed HPTLC method is simple, sensitive, precise a