Discussion and Summary
The process of validating a newly developed HPLC-based analytical method intended to measure API and impurities in the drug samples employ a series of different tasks and experiments. The validation process of the new method would test the principles of operation of the chromatographic method. Some of the basic principles of operation of the method include retentions, resolution and sensitivity.
The first experiment that would be conducted to evaluate and validate the newly developed HPLC-based analytical method would be based on the retention. The retention of a drug with a specific packaging substance and eluent can be demonstrated as a retention volume or retention time (Agalloco and Frederick 547). The retention volume is regarded as the quality of the mobile phase needed to pull the sample via the column. The validation process will test the retention time: the amount of time a substance is retained in the column by immobile phase about the amount of duration it stays in the mobile phase. As a result, the retention is described ration of the column capacity which can be utilized to examine the efficiency of the column.
Apart from retention, the other test used is the resolution test. It is the ability of the column to separate different peaks on the chromatograph (Agalloco and Frederick 547). It is expressed as the quotient of the distance between the two peaks maxima and the average value of the peak width at the ground line.
Also, the sensitivity of the method shall be evaluated to determine the measure of the smallest level of a substance that can be detected in a chromatographic separation. It should be noted that sensitivity is dependent on the ratio of the signal to noise in a specific detector.
Works Cited
Agalloco, James P, and Frederick J Carleton. Validation Of Pharmaceutical Processes. New
York: Informa Healthcare, 2008. Print.
