Applications of various analytical techniques in quality control of pharmaceutical excipients

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Abstract

Although excipients are pharmacologically inert substances, still they are integral and significant ingredients of a pharmaceutical formulation. Their amount and concentration level along with the active pharmaceutical ingredients is of utmost importance to decide the pharmacokinetics and stability of a dosage form. It is becoming progressively more important to illustrate the purity of excipients throughout the development and manufacture of pharmaceutical products as the safety and efficacy of the pharmaceutical formulation is largely affected by the quality of excipients. Therefore it is essential to analyze these excipients by suitable analytical technique before their incorporation into the formulations. In the present review authors have summarized the reported applications of various analytical techniques being used in excipients analysis. These include capillary electrophoresis, static headspace capillary gas chromatography, gel permeation chromatography/size exclusion chromatography, LC-IR hyphenated technique and Near IR etc. Various parameters and conditions optimized are also described along with the techniques.

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