Bulk Solution Assay Test Procedure Development and validation for Esomeprazole Sodium Injection 40mg as a CPP

摘要

Assay analytical test procedure at the Bulk-Solution stage for Esomeprazole Sodium Injection 40mgas a Critical Processing Parameters during manufacturing developed and validated. As per current available literature and the references, Esomeprazole active substance is available in market in the five forms, i.e. Esomeprazole as Plain [Tablet]; Esomeprazole Magnesium Trihydrate [Tablet, Capsule Delayed Release]; Esomeprazole Potassium [Tablet and Capsule]; Esomeprazole Strontium [Capsule Delayed Release] and Esomeprazole Sodium [Injectable].Assay test procedure for Active and other dosage forms [Tablet, Capsule] were available based on either Potentiometric Titration or HPLC basis. Product Esomeprazole Sodium Injection 40mg is not available in official pharmacopeia. As per available reference and literature assay test method for intermediate testing and finished product is based on HPLC. Intermediate testing [In-Process Testing] required as Critical Process Parameters [CPP] to ensure the quality i.e. appropriate bulk-solution purity, before to proceed for filtration and filling of Bulk-solution in unit dosage form [Vials]. To test the bulk solution purity approximate 5-6 hours required by HPLC. Which leads to hold the Bulk solution, further it impact and may risk to Bio-Burden of bulk solution. Also it impact and reduce the productivity of line by 5-6 hours. HPLC testing required special skilled manpower and cost. Considering all above concerns Study carried for test method development based on UV-Spectroscopy, HPLC and potentiometric titration. Based on method validation performed for UV-Spectrometry, HPLC and potentiometric titration; Test procedure developed and validated based on UV-Spectrometry is found Simple, Accurate, Precise, Economical and Rapid to save time and cost with increase in productivity as a Critical Processing Parameters for Esomeprazole Sodium Injection 40mgat the Bulk-Solution stage during manufacturing.