A Validated Stability-indicating Reverse Phase HPLC Assay Method for the Determination of Memantine Hydrochloride Drug Substance with UV-Detection Using Precolumn Derivatization Technique

• Published in: Analytical chemistry insights Vol. 2010; no. 5; p. 37
• Main Authors: Narola, Bhavil, Singh, A.S., Santhakumar, P. Rita, Chandrashekhar, T.G.
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publishing 20.07.2010; SAGE Publications; Sage Publications Ltd. (UK)
• Subjects: Aluminum compounds; Analysis; Chemical tests and reagents; Chromatography; Detectors; Hydrochloric acid; Hydrogen peroxide; Hydroxides; Methods; Nervous system agents; Nitriles; Peroxides; FMOC; precolumn derivatization; assay; HPLC; memantine hydrochloride
• ISSN: 1177-3901; 1177-3901
• DOI: 10.4137/ACI.S3936

Bhavil Narola, A.S. Singh, P. Rita Santhakumar and T.G. ChandrashekharRanbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Complex, Gurgaon-122001, Haryana, India. AbstractThis present paper deals with the development and validation of a stability indicating high performance liquid chromatographic method for the quantitative determination of Memantine hydrochloride. Memantine hydrochloride was derivatized with 0.015 M 9-fluorenylmethyl chloroformate (FMOC) and 0.5 M borate buffer solution by keeping it at room temperature for about 20 minutes and the chromatographic separation achieved by injecting 10 µL of the derivatized mixture into a Waters HPLC system with photodiode array detector using a kromasil C18 column (150 × 4.6 mm), 5 µ. The mobile phase consisting of 80% acetonitrile and 20% phosphate buffer solution and a flow rate of 2 milliliter/minute. The Memantine was eluted at approximately 7.5 minutes. The volume of FMOC used in derivatization, concentration of FMOC and derivatization time was optimized and used. Forced degradation studies were performed on bulk sample of Memantine hydrochloride using acid (5.0 Normal (N) hydrochloric acid), base (1.0 N sodium hydroxide), oxidation (30% hydrogen peroxide), thermal (105°C), photolytic and humidity conditions. The developed LC method was validated with respect to specificity, precision (% RSD about 0.70%), linearity (linearity of range about 70-130 µg/mL), ruggedness (Overall % RSD about 0.35%), stability in analytical solution (Cumulative % RSD about 0.11% after 1450 min.) and robustness.