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

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A stability-indicating liquid chromatographic method for Lomustine.

K Rama Seshaiah¹, Sudip Kr Samanta, V Krishna Reddy

¹Dr. Reddy's Laboratories Ltd., Active Pharmaceutical Ingredients, IPDO, Bachupally, Hyderabad 500072, AP, India; Center for Pharmaceutical Sciences, IST, J.N.T. University, Kukatpally, Hyderabad 500072, India.

Journal of Pharmaceutical and Biomedical Analysis

|August 20, 2010

Summary

This summary is machine-generated.

A new liquid chromatography (LC) method accurately quantifies Lomustine, a chemotherapy drug. This validated method effectively separates Lomustine from impurities and degradation products, ensuring reliable drug analysis.

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Lomustine is a crucial chemotherapy drug requiring precise quantification.
Assessing drug stability through degradation studies is vital for pharmaceutical quality control.

Purpose of the Study:

To develop and validate a simple, inexpensive, and rapid liquid chromatography (LC) method for Lomustine determination.
To evaluate the stability of Lomustine under various stress conditions.

Main Methods:

Quantitative analysis of Lomustine using a Symmetry C 8 LC column.
Method development involved optimizing a mobile phase of potassium dihydrogen phosphate and acetonitrile.
Degradation studies included heat, UV/visible light, acid/base hydrolysis, and oxidation.

Main Results:

The developed LC method achieved good resolution between Lomustine, synthesis impurities, and degradation products.
Mass balance for degradation samples was consistently close to 99.9%.
The method was validated according to International Conference on Harmonization (ICH) guidelines.

Conclusions:

A robust and efficient LC method for Lomustine quantification has been successfully developed.
The method demonstrates suitability for stability testing and quality control of Lomustine formulations.