Investigation of linearity, detection limit (LD) and quantitation limit(LQ) of active substance from pharmaceutical tablets

Abstract

The aim of this research was to exactly quantify pure sodium metamizole from tablets , using a spectrophotometric analysis in Visible range. The method applied has been subjected to a validation protocal which consisted in analyzing the following parameters: linearity of the method, detection limit (LD) , quantitation limit (LQ). Following actual dosing, pure sodium metamizole amount in tablet of pharmaceutical was found to be 477.477 mg assigned to a percentage content of 95.495 %, very close to official declared amount (500 mg), with an maximum average percentage deviation of only 4.505 % from the official declared active substance content. This value was situated below the maximum admissible percentage deviation from stated active substance content (± 5%), established by Romanian Pharmacopoeia, X-th Edition rules.