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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

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LC method for telithromycin in tablets: a stability-indicating assay.

Lauren C Vaucher¹, Clésio S Paim, Alini D Lange

¹Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Porto Alegre-RS, Brazil. lauvau@terra.com.br

International Journal of Pharmaceutics

|November 4, 2008

Summary

This summary is machine-generated.

A new liquid chromatography method accurately quantifies telithromycin, a ketolide antibiotic. This validated analytical method is suitable for quality control and stability testing of telithromycin formulations.

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Telithromycin is the first member of the ketolide class of macrolide antibiotics.
Development of robust analytical methods is crucial for pharmaceutical quality control.

Purpose of the Study:

To develop and validate a liquid chromatographic (LC) method for the quantitative determination of telithromycin.
To assess the method's suitability for analyzing telithromycin in pharmaceutical products and for stability studies.

Main Methods:

High-performance liquid chromatography (HPLC) using an Ace RP-18 column.
Methanol and potassium phosphate buffer as mobile phase, UV detection at 265 nm.
Forced degradation studies (acid, base, oxidation, UV, heat) to assess specificity.

Main Results:

The method demonstrated excellent linearity (r=0.9999), precision (RSD < 2.0%), and accuracy (100.76% recovery).
High specificity was confirmed, with no interference from degradation products or excipients.
Low detection (0.0027 µg/mL) and quantitation (0.0082 µg/mL) limits were achieved.

Conclusions:

The validated LC method is sensitive, specific, robust, and suitable for quantifying telithromycin in tablets.
The method can be used for drug stability determination and is interchangeable with microbiological assays.