DEVELOPMENT AND VALIDATION OF LC-MS/MS METHOD FOR QUALITY CONTROL OF MEMANTINE HYDROCHLORIDE TABLET FORMULATION

The objective of present study was to develop an extraction and liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical method for the analysis of Memantine Hydrochloride (Mn-HCl) in drug formulation (tablet). The core advantage of the extraction method is to avoid interfering excipients, which has ever been dilemma for previous researchers, without any long and tedious effort prior to analysis on LC-MS/MS. A reverse phase Thermo gold RP C-18 (4.5 ×250cm) column fitted in LC-MS was used with gradient elution of mobile phase (0.1 % formic acid and methanol) which resulted efficient analysis in just ten minutes runtime at ambient temperature. To make the result authentic, tandem mass spectrometry was also performed observing a most stable fragment at m/z 163 of parent ion m/z 180. For the validation of method precision, accuracy and linearity have been quantified. Limit of detection and limit of quantification were found to be 0.03 and 0.1respectively. Linearity was calculated over a range of 0.625-8 mg/L of standard with regression > 0.99. This method is easy and efficient (recovery > 99 %). The proposed method can be used as a method of choice in any quality control laboratory for routine analysis of Mn-HCl in tablet formulations.