I got 88.0 % assay for a drug in HPLC analysis for same
injection i got 40.0% related substances is it possible?
what is the relation between results of assay and purity?
Answer Posted / s chatterjee
in Gabapentin, Imp A has a RRF of 12.6 i.e. against gabapentin standard. Say Gabapentin has degraded 12 % i.e. 88 % assay ( quantitative only) . When rel subs was calculated the Imp A against the gabapentin standard will give an quantitative value of 36 %. however, in reality as the correction factor is 12.6 then this comes to 36/12 = 3 % in reality.
Therefore it is important to know that the correction factor of related substances had been established against the drug used for quantification. Response of degradation products varies significantly from the drug candidate under UV.
Is This Answer Correct ? | 2 Yes | 0 No |
Post New Answer View All Answers
Why six unit used for precision?
if your product is soluble in 0.1n hcl and water then which you choose as media from these 2 media?
What is dose dumping? why require to do?
What is viod volume and peak purity in HPLC?
WHICH STANDARD WE USE IN SILICA ANALYSIS IN SILICA-GEL METHOD FOR SOLID SAMPLE
what are the guidelines for analytical method validations?
How to determine water content of bis tetrazole amine mono ammonium salt
How can I develope method of dissolution by HPLC OR UV
in which situation ion pair require to use?
how to calibrate hplc & gc
How can the GC or HPLC method is selected to determine the impurity profile in drug product?
How to start the dissolution development for unknown tab?
What is the principle of HPLC, GC, LCMS, GCMS,LC QQQ, GC QQQ, LC Q TOF and GC Q TOF. What are the applications and Specificity?
1)What's the meaning of Absorption,give a example. 2)What's the meaning of Adsorption,give a example. 2)what is the difference between Absorption and Adsorption.
Why a1% value is used for some product ? What is the criteria for selection a1% value ?