Application of fluorotag in quantification of metformin in tablet dosage form and biological samples:(TJPS-2021-0072.R1)

Abstract

Background: New specific and sensitive spectrofluorimetric fluorotag method has been developed and validated for the quantification of metformin hydrochloride (MET). 
Methods: The derivatization reaction was carried out using 1, 2 napthaquinone-4-suphonate as (NQS) fluorotag in the presence of strong alkaline medium (potassium hydroxide) to form the highly fluorescent product. The fluorescence was observed at emission wavelength 453 nm after excitation at 359 nm. The different experimental conditions affecting the reaction product formation and stability were carefully studied and optimized as 2% w/v of potassium hydroxide solution, 0.5% w/v NQS reagent. 
Results: At optimum reaction conditions, good linear relationship were found and Beer’s law range was found to between 5-30 µg/mL, (R²=0.999). As per ICH guidelines the validation parameters were satisfied (% RSD<2.0) for accuracy and precision studies. LOD and LOQ for proposed method was found to be 0.54 µg/mL and 1.6 µg/mL, respectively. 
Conclusion: The contemplated method was successfully employed for quantification of metformin in pharmaceutical dosage form, spiked human plasma and urine samples.