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A 0.01 % solution of paracetamol API was analysed by HPLC giving a peak at 4.35...

A 0.01 % solution of paracetamol API was analysed by HPLC giving a peak at 4.35 minutes from a c18 5 micron column. The peak area is 159785643. The peak area of a 0.05 % paracetamol standard is 80045687. Calculate the % assay for paracetamol API. Do you think this would comply with release specification of an active drug substance?

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Expert Solution

Ans: The % Assay in HPLC analysis can be calculated as per the below formula:

Conc. of Standard       Peak Area of the Sample

% Assay = ------------------------- x ------------------------------------- x 100

                     Conc. of Sample       Peak Area of the Standard

Substituting the given values in the formula:

0.05          159785643

% Assay of Paracetamol API = ---------- x ------------------- x 100

0.01 80045687

= 998.1 %

This is a wrong value. It is clear that the standard is very impure and giving very low area compared to the sample. That is why the assay is obtained as an unexpected value. The API can not be released. Need to check the standard and all preparations for the errors.

queen_honey_blossom answered 1 year ago
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