may i know how to analyze rabe + dome pellet loaded capsules.
in IP there is no specification regarding pellet analysis, so whether we can go for analysing it using Manufacturer specification analysing method…
You can analyse pellets of Domeperidone & Rabeprazole according to IP monograph of capsules (finished product) or as per the pellets manufacturer’s specifications. However, please ensure that the specification of pellets must be same as given in IP for capsule finished products, specifically for dissolution profile and assay.
The quantity of pellets (Domep + Rabep) to be filled in one capsule is very critical to get assay of these ingredients as per IP monograph of finished product capsules.
Thankyou for your reply, but there is no IP monograph for rabe+dome capsules.
what said in it is seperate monograph of respective finished products and not as combined.
& what DI was expecting is, whatever the analysis done by us isnt a concern (either Manufacturer specification or method developed and validated by us), but it should coplies with IP ionce they analysing it.
But the problem is with dissolution of Rabeprazole IP method. On subjecting the capsule in acidic medium for 2hrs (as per IP), the domeperidone was also getting dissolved-dissoluted in that medium, upon analysing it on UV, the dome was also reflected which lead to increased amount of rabe i.e % of rabe is about 120%, exceeding the limit.
This is what we facing sir, so please let me with solution…
Thanks for your clarification.
I think there are two issues here.
Firstly, the combination of (Domep + Rabep) is not in IP monograph. Is it available in other Pharmacopoeia, like USP, BP, EP etc. If yes please follow the mrthod of analysis as per that Pharmacopoeia. If not, means this is a properitary medicine. You can have your in-house specification of capsules (Finished product)
Secondly, the analytical method of dissolution test. The teat in IP is given for single ingredient of Rabeprazole. So there will not be interference of any other active ingredient in analysis as per IP.
However, your product is in combination. Hence you are getting interference of Domeperidone by UV test method for analysing Rabeprazole. This UV method is not specific.
Therefore, please develop & validate HPLC method which will be more specific, accurate & precise with respect to Domeperidone & Rabeprazole analysis (in one injection you should get two peaks of Domeperidone and Rabeprazole). Please ensure that you validate the HPLC method as per ICH guidelines. Then you should not face any problem.
Please remember that for any method adopted from either any pharmacopoeia or any scientific jouranl or furnished by the manufacturer / supplier of that API must be fully validated and or verified (partial validation) for its suitability for your product. If found satisfactory only then you should follow that method. During any regulatory inspection analytical method validation specifically for non-pharmacopoeial products (assay, impurities, Residual solvents analysis) are checked and audited.
Alternatively, you may also develop separate HPLC methods of dissolution of Domperidone and Rabeprazole, if their dissolution profiles are different and time / dissolution media (acidic or basic) dependent.
Thank you for your valuable suggestion…
You are always welcome.
I have another doubt on another product. the problem with the product is bulging of strip packing & API used was cefixime trihydrate and cloxacillin sodium with lactobacillus spores.
Upon packing, there s no problem but from the 4th month it starts bulging. The bulging is because of release of gas and once u tare the strip u can smell that too which isn’t smell of API but some other.
we have also taken some trials, but it fails to overcome those. So, let me with the solution for this problem.