METHOD VALIDATION FOR THE DETERMINATION OF WATER CONTENT OF METERED DOSE INHALER BY KARL FISCHER COULOMETER
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 7
Abstract
This study aimed to validation of water content determination method of inhaler by Karl Fischer Coulometer to outline a simple procedure. The system suitability test was performed by injecting standard solution (0.1% water standard).The average % recovery was found 99% which is within the acceptance limit of 95% to 105%. From the specificity study, it was observed that there was no response in case of blank (without sample or standard) measurement, and the spike sample (with 0.1%water standard) showed positive response. In the linearity study the squared correlation coefficient was found to be 0.999, which indicated that the method was linear. It was observed that %RSD of system precision, repeatability, and intermediate precision were 3%, 6% and 7% respectively which was within the acceptance limit (5% for system precision and 10% for repeatability and intermediate precision).The result of accuracy in terms of average % recovery of water was 99% with average %RSD 1% and 95% confidence interval was 97.58 to 99.98. The method was found to be robust for changing titrant source, titrant volume and rotation of stirrer. The titrant was found to be stable up to 24 hours. So, it can be a good alternative to existing methods for water content determination.
Authors and Affiliations
Mohammad Momin , Afrina Afrose , S. M. Masud , Sharif Anisuzzaman
Keywords
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