DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR NEWLY SYNTHESIZED 3,6-DICHLORO-6-{[(6-METHOXY-1,3-BENZOTHIAZOL-2-YL)IMINO]METHYL}PHENOL

Main Article Content

Omkar Kulkarni
Mahesh P More
Mahesh B More
Parasnath Bele

Keywords

Method Validation, Analytical method development, High-performance liquid chromatography, pharmaceutical formulation

Abstract

This study presents the development and validation of a reverse-phase high-performance liquid chromatography (RP HPLC) method for the analysis of 3,6-dichloro-6-{[(6-methoxy-1,3-benzothiazol-2-yl)imino]methyl}phenol (DCMBT). The analysis was conducted on a HYPERSIL column (250 x 4.6 mm, 5 µm) using a mobile phase consisting of Acetonitrile: Water (80:20v/v) at a flow rate of 0.8ml/min. The detection was performed using UV at a wavelength of 249 nm. The DCMBT had a retention time of 5.742 minutes. The compound DCMBT exhibited a direct relationship between its concentration and response within the range of 4-24 ppm. The correlation coefficient of DCMBT was 0.999. The created technique underwent validation for linearity, accuracy, precision, selectivity range, force degradation study, and robustness. The results of the validation confirmed that the method is exact, accurate, linear, and specific. The approach was verified by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) criteria. The relative standard deviation (RSD) for both intra-day and inter-day precision was determined to be below 2%. The percentage recoveries achieved for isoeugenol DCMBT fall within the range of 98.74 - 101.11%, with an overall mean recovery of 99.59%. These results demonstrate a high level of agreement with the labeled amount in the pharmaceutical formulations

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