Abstract

A cost-effective and unique RP-HPLC technology has been developed to correctly and precisely quantify the amount of Metolazone in both bulk amounts and solid dosage forms. The separation procedure was performed with an Inertsil ODS-3 HPLC Column with a particle size of 5 µm and dimensions of 250 x 4.6 mm. The experiment used the isocratic method, with a mobile phase composed of an 80:20 (v/v) blend of Acetonitrile and methanol. A pump was used to introduce the mobile phase into the column at a flow rate of 1.0 mL min-1. The eluent from the column was identified using a UV detector configured to function at a wavelength of 295 nm. The experiment lasted for 8 minutes, during which the column was continually maintained at the surrounding temperature. The calculated retention time for Metolazone was 3.557 minutes. The standard curves demonstrated a consistent linear correlation over the concentration range of 02-10 µg/ml, with a very high coefficient of determination (R2 = 0.9997). The investigation yielded a range of percentage recoveries, spanning from 98% to 102%. In addition, the Relative Standard Deviation (RSD) was calculated to be 0.290%. The percentage content of a commercially available version of Metolazone was tested to be 100.18%. The technique was validated in compliance with the guidelines established by the International Council for Harmonisation of Technical guidelines for Pharmaceuticals for Human Use (ICH). The proposed RP-HPLC technology has undergone validation via study, demonstrating its attributes of simplicity, specificity, speed, reliability, and consistency. Hence, the methodology proposed in this research may be used for the routine examination of Metolazone in both its concentrated and solid forms, particularly with the objective of ensuring quality assurance.

Description