Method Development and Verification for Dissolution of Magnesium Oxide Tablets 400 mg by Titration
DOI:
https://doi.org/10.26438/ijsrcs.v12i1.181Keywords:
Dissolution, Magnesium Oxide Tablets, HPLC, Titration, Conductivity Suppression Detector (SCD), ICH guideline, Atomic Absorption Spectroscopy (AAS)Abstract
Dissolution analysis by HPLC for Magnesium Oxide Tablets 400 mg with Conductivity Suppression (SCD) Detector and/or by Atomic Absorption Spectroscopy as per current USP monograph method is quite difficult and non-feasible due to non-economical availability of SCD detector and Atomic Absorption Spectroscopy. Hence, Dissolution analysis by Titration method for Magnesium Oxide Tablets has been developed using 0.025M Edetate disodium VS as titrant for titration method. The Dissolution Tolerance is NLT (Q) 75% of the labelled amount of Magnesium Oxide is dissolved. The method was validated as per ICH Quality guidelines Q2(R2) Validation of Analytical Procedure with specificity, precision, linearity and accuracy. The study findings obtained the coefficient correlation of 0.9998 for linearity and %RSD of 2.9 with 91% of average dissolution for precision. The recovery results of 50%, 100% and 120% ensures the accuracy of the method with 100.1%, 98.1% and 97.0% respectively.
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