Pharmacy Courses

Why Should We Establish the Stability of Mobiles Phase?

It is a study of the time interval within which the mobile phase retains its integrity and can be relied to give accurate and consistent results when stored at room or controlled temperature.

Reproducibility and Consistency:

Mobile phase stability is essential to achieve consistent and reproducible results in chromatographic analyses. Fluctuations or changes in the mobile phase composition can lead to variations in retention times and peak shapes, making it difficult to compare results across different experiments or laboratories.

Data Accuracy:

The stability of the mobile phase directly impacts the accuracy of quantification and identification of compounds in a sample. Inaccurate mobile phases can lead to misinterpretation of results, affecting the quality of analytical data.

Baseline Drift Prevention: 

A stable mobile phase helps maintain a stable baseline in chromatograms. Baseline drift, caused by mobile phase instability, can obscure or distort chromatographic peaks, making it challenging to identify and quantify compounds.

Selectivity and Resolution: 

The composition of the mobile phase plays a crucial role in separating compounds in a sample. Stable mobile phases help maintain selectivity and resolution by ensuring that the separation conditions remain constant throughout the analysis.

Column Protection: 

An unstable mobile phase can lead to column damage, reducing the column's lifespan and requiring more frequent replacement. A stable mobile phase helps protect the integrity of the chromatographic column.

Time and Cost Efficiency: 

Once the Stability of Mobile phase is proved/ Established, the same mobile phase can be used for the specified time which will reduce the time and cost for preparation of new one. 

Data Integrity: 

ensuring the stability of the mobile phase is crucial for data integrity and compliance with good laboratory practices (GLP) and good manufacturing practices (GMP).

The study is usually carried on replicate Standard solution, Resolution solution or System suitability to check the if System suitability criteria is within the acceptance criteria with the Mobile phase used after 24 hours, 48 hours etc.

The established stability of the mobile phase should be recorded and made a part of the Analytical method.

Read also: 

Previous Post Next Post