Jump to main content
Jump to site search

Issue 1, 2010
Previous Article Next Article

Development & validation of an in vitro dissolution method with HPLC analysis for misoprostol in formulated dosage form

Author affiliations

Abstract

The intended purpose of this work is to develop and validate a dissolution test for misoprostol tablets containing 200 μg misoprostol [1% in hydroxypropyl methylcellulose {HPMC}] using a reverse-phase liquid chromatographic method. After testing sink conditions, dissolution medium and stability of the drug, the best conditions were: paddle at 50 rotations per minute (rpm) stirring speed, deaerated water dissolution medium with volume of 500 ml, as per very low label content of the drug substance & drug product. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, precision, linearity and accuracy. Release of more than 85% of the label amount was achieved over 30 min in the medium through out the study. The dissolution test developed was adequate for its purpose and could be applied for quality control of misoprostol formulation dosage form.

Graphical abstract: Development & validation of an in vitro dissolution method with HPLC analysis for misoprostol in formulated dosage form

Back to tab navigation

Publication details

The article was received on 26 Sep 2009, accepted on 30 Oct 2009 and first published on 13 Nov 2009


Article type: Paper
DOI: 10.1039/B9AY00188C
Anal. Methods, 2010,2, 72-75

  •   Request permissions

    Development & validation of an in vitro dissolution method with HPLC analysis for misoprostol in formulated dosage form

    J. Mehta, K. Patidar, V. Patel, N. Kshatri and N. Vyas, Anal. Methods, 2010, 2, 72
    DOI: 10.1039/B9AY00188C

Search articles by author

Spotlight

Advertisements