Quantification of lysine clonixinate in intravenous injections by NIR spectroscopy

Migraine is a very painful and somewhat unpredictable ache that affects millions of people worldwide and for which no definite medicine exists, yet. New drugs and/or pharmaceutical forms are being developed, for which new quantitation methods are required. Lysine clonixinate (LC) has proved very advantageous to alleviate migraine episodes although, so far, no analytical procedures have been reported to quantify it in pharmaceutical dosage forms usually employed by physicians, i.e., injectable solutions. In this paper a NIR spectral method was developed and validated against international pharmaceutical standard guidelines and a new UV-based method to quantify LC in intravenous injection solutions. Both methods are almost inexpensive, fast, simple and suitable for LC routine determination. In addition, they provide analytical protocols less time-consuming than other reported HPLC methods (developed for other matrices), proved to be specific, accurate, precise and linear within the typical working range, according to the Harmonized Tripartite Guideline of Validation of Analytical Procedures from the International Conference on Harmonization. Both methods yield equivalent results and they are useful to monitor the concentration of LC in injectable solutions in routine analysis.