Utilization of cloud point extraction for enhancement the efficiency of spectrophotometric estimation of milnacipran HCl as anti-depression drug in dosage forms and application to its tablets uniformity testing

Abstract

Two spectrophotometric techniques that are straightforward, sensitive, accurate, and precise have been created and validated for the detection of a particular antidepressant drug, milnacipran HCl (MCN), in both pure and dosage forms. The method A was based on the reaction of MCN with p-dimethylaminobenzaldehyde (p-DMAB) in an acidic medium, to give a yellow colored Schiff’s base product that can be measured at a maximum wavelength of 400 nm. The concentration range of 60–300 μg/mL, with an excellent correlation coefficient (r2 = 0.9991) and with a relative standard deviation (RSD% = 2.0), complies with Beer’s law under ideal circumstances. The method B approach uses a cloud point extraction (CPE) methodology to measure the amount of the yellow color product utilizing Triton X-114 and cetyltrimethylammonium bromide (CTAB) as surfactants at a maximum wavelength of 410 nm. Beer’s law was obey in the concentration range of 0.2–4.0 μg mL−1, a correlation coefficient (r2 = 0.9995) and a relative standard deviation of (RSD% = 1.70). The best optimized reaction circumstances, including the type of solvent, reagent concentration, reaction time, and molar ratio. Calculations were made about the detection and quantification limits. No interference was seen with the frequently used excipients and additives. The proposed methods for determining MCN in its pharmaceutical formulations were effectively used, and the results for pure MCN and commercial tablets were in good agreement with those from the reported approach.