I am performing validation for spectrophotometric method for dissolution test. Do I need to test the system suitability of spectrophotometer as in HPLC I inject 6 replicate of standard preparation at 100% level. Anyone share me a protocol template for method validation.
Thank you very much!
there is no need to perform system suitability of spectrophotometric methods. for dissolution method validation, you may refer to USP <1092>.
Hi,
yes you have to perform system precision. Prepare standad solution as per the method and perform 5 consecutive meserments at the specified nm.
record mean and %RSD in the report.
Regards,
Anand
Dear Abhakar,
As you said correct. For dissolution validation we have to do system precision with 100% concentration of standard solution should check the method nm with 10 replicates or five replicates as per your internal protocol.
Regards
Senthilkumar
Not required,
No guideline is specifying system precision. we should call it as system suitability.
If anywhere in the officia guideline named system precision, Please send the link or guideline with system precision, so that i will be grateful to you.
As far as i know, system precision is not included in any guideline
Coming to the point, Spectrophotometric methods does not carry any system suitability tests, There is no official requirement of system suitability or you said system precision for spectoscopy mehtods like UV. No where it is written that valiation needs system precision .
Better to avoid the terminology system precision.
system suitability in terms of instrument verification. %RSD etc…
Regards,
Bujji Reddy K
Hetero drugs Limited
9676749937.
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Dear Bujji reddy,
Please find the attachement file. In this file havine the system repeatability under precision.
Regards
e_senmail
AOM-11.pdf (167.9 KB)
Hi,
system repeatability is given in the attachment.
This is nothing but system suitability
This kind of test conventionally carried out in every assay or Related substances testing as a common practice.
Its not special for validations.
Regards,
Bujji Reddy Kanchi.
+91-9676749937