3.3.4. Precision
Instrumental precision was determined by six replicate determinations
of standard solution, relative standard deviation was calculated
and found to be 0.49% for sodium hyaluronate
Method precision or intra-assay precision was performed by
preparing six different samples from the same sample pool. Each
solution was injected in triplicate under the same conditions and
mean value of peak area response for each solution was taken. The
relative standard deviation of sodium hyaluronate in six sample
solutions was calculated. Relative standard deviations obtained for
sodium hyaluronate was 0.51%.
Intermediate precision was performed by analyzing the samples by
two different analysts employing different instruments. Standard
solution and six different samples at 100% target level were prepared
by each analyst. Relative standard deviation obtained from 12 assay
results by two analysts was 0.61% for sodium hyaluronate