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Topic: Method of validation-Accuracy criteria calculation  (Read 2161 times)

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Offline Mohsinkhan101

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Method of validation-Accuracy criteria calculation
« on: August 31, 2015, 03:11:08 PM »
we were working on method of dissolution for atenolol and go on for validating it,Linearity, precision,robustness,every single results come well n good,but we are stuck on this accuracy studies...the procedure is as given below:-

The recovery study was performed using a well-characterized lot of drug product with tight content uniformity. Atenolol reference substance was added to the dissolution vessels in known amounts at the 80%, 100%, and 120% levels. Accordingly, 35mg,50 mg and 70 mg of reference drug was added along with each 50 mg tablet. The dissolution test was performed on Atenolol tablets for 30 min. Analyzing the sample at 226 nm on UV

How to make calculation  after that,,all we can find is percentage of the drug release,but we need result in mg/ml,how to find amount of atenolol recovered in mg/ml?

Offline Arkcon

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Re: Method of validation-Accuracy criteria calculation
« Reply #1 on: August 31, 2015, 04:18:00 PM »
It might be helpful to see your numbers in table form, it would also likely help you.  Briefly, 100 % recovery in the sample that was at 100 % would be exactly the calculated mg/ml for if you simply dissolved it in solvent.  So that's what you'll want to compare to.  Its hard to describe, but that's all there is to it.  Let's try to see a table of values -- theoretical and experimental observation.
Hey, I'm not judging.  I just like to shoot straight.  I'm a man of science.

Offline Mohsinkhan101

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Re: Method of validation-Accuracy criteria calculation
« Reply #2 on: September 01, 2015, 09:48:59 AM »
Thanks a lot for the reply, Even we are working in tabular form for better understanding. Ok,i can tell u what results we got for atleast one ,for added amount of 35,,after going through all process and calculation we get the dissolution result 116%,,we know the drug release after 30 min is 116% and if we compared to only drug(no spiking), then result comes out to be 104%. We are following procedure but cant find a way to calculate this in mg/ml.

Table 2. Dissolution test Accuracy results for Atenolol
Sr.no    Parameter                       Levels
1   Tablet amount (mg)   50   50   50
2   Level of addition (%)   80   100   120
3   Amount added (mg)   35   50   70
4    Release of drug (%)  116
5   Avg amount recovered  ?       ?       ?         
6   Average % recovery*         
*Each reading is mean ± SD(n=3)
« Last Edit: September 01, 2015, 09:59:51 AM by Mohsinkhan101 »

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