Calculating %Assay for HPLC Stability Study

  • Thread starter ChemiePham
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In summary, the conversation revolves around calculating the %assay for active and degradants in a stability study. The person has assayed the t=0 timepoint using HPLC and has the range of concentrations for the formulations, but is unsure of how to proceed. They have run a standard and calculated the concentration based on response factor, but are now stuck and seeking guidance. They are asked about the data obtained, how the materials are being analyzed, the resolution of degradants from the peak of interest, and the variation of response with concentration. They are also asked about the peak height or area of the test material compared to the low and high concentrations of standards.
  • #1
ChemiePham
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I am running a stability study and have assayed by HPLC my t=0 timepoint. I only have the range of concentrations for the formulations...how do I go about calculating the %assay for the active and degradants?

I ran a standard during the run and have calculated the concentration by based on my response factor but after that I am stuck...
 
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  • #2
When you ran the study, did you obtain data? Are you analyzing your materials by peak height or by area? Are the degredants well resolved from your peak of interest? How does the response... either by peak area or peak ht., vary with concentration? Is the peak ht. or peak area of your test material between that of the low concentration and high concentration of your standards?
 
  • #3
chemisttree said:
When you ran the study, did you obtain data? Are you analyzing your materials by peak height or by area? Are the degredants well resolved from your peak of interest? How does the response... either by peak area or peak ht., vary with concentration? Is the peak ht. or peak area of your test material between that of the low concentration and high concentration of your standards?

Hi,

I am really having a sort of confusion here and I think that I have to search about this little much, by far it is like a sort of question that I am some where thinking of as, please if you find some good knowledge about this then do let me know.


Thanks!
 

What is %Assay and why is it important in HPLC stability studies?

Assay is the measurement of the amount or concentration of a specific substance in a sample. In HPLC stability studies, it is important because it allows us to determine the purity and potency of a drug or compound over time.

How is %Assay calculated in HPLC stability studies?

%Assay is calculated by comparing the peak area of the sample to a known standard. This allows us to determine the percentage of the compound present in the sample.

What factors can affect the accuracy of %Assay in HPLC stability studies?

Some factors that can affect the accuracy of %Assay include changes in sample preparation, instrument calibration, and degradation of the compound over time. It is important to carefully control these factors to ensure accurate results.

What is the acceptable range for %Assay in HPLC stability studies?

The acceptable range for %Assay can vary depending on the specific drug or compound being studied. Generally, it is expected to be within 98-102% for pharmaceutical products. However, for research purposes, a wider range may be acceptable.

How often should %Assay be measured in HPLC stability studies?

The frequency of %Assay measurements can vary depending on the specific study and the stability of the compound being tested. However, it is typically measured at regular intervals (e.g. weekly, monthly) over the course of the stability study to track any changes in purity and potency over time.

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