Method Development and Verification for Dissolution of Magnesium Oxide Tablets 400 mg by Titration

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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Publication Details

Journal
International Journal of Scientific Research in Chemical Sciences
Published
2025-02-28
DOI
https://doi.org/10.26438/ijsrcs.v12i1.181
Primary Topic
Pharmacy and Medical Practices
Type
article
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article

Method Development and Verification for Dissolution of Magnesium Oxide Tablets 400 mg by Titration

Chinmaykumar Oza
International Journal of Scientific Research in Chemical Sciences
Pharmacy and Medical Practices
article

Method Development and Verification for Dissolution of Magnesium Oxide Tablets 400 mg by Titration

Chinmaykumar Oza
article en

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.

International Journal of Scientific Research in Chemical SciencesVol. 12(1)
Windsor Dermatology (US)
Openalex Percentile: Top 87%
Pharmacy and Medical Practices
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