Development and Validation of Extractive Spectrophotometric Method for Estimation of Hydroxychloroquine Sulphate by using Smartphone Application

Abstract

A simple, sensitive, accurate, precise and reproducible extractive spectrophotometric method was developed for estimation of Hydroxychloroquine Sulphate (HCQS) in bulk and pharmaceutical dosage form. The method is based on formation of ion pair complex of Hydroxychloroquine Sulphate with Bromocresol green dye in acidic medium. This complex extracted in chloroform and measured quantitatively at 421nm for estimation of Hydroxychloroquine Sulphate present in the sample. In this method estimation was also done by using Smartphone Application known as PhotoMetrix pro. Beer Lambert’s law obeyed over a range of 2-10 μg/ml for HCQS by UV spectrophotometric (r²=0.9988) and by SmartPhone Image analysis (r²=0.999) method. The developed method was successfully applied for estimation of Hydroxychloroquine Sulphate in three commercial product tablet dosage form without interference from common additives. The assay was found to be 100.09%, 100.8%, 98.6% by UV and 99.2%, 101.46%, 101.1% using PhotoMetrix for three formulation containing Hydroxychloroquine Sulphate. The developed method was also validated according to ICH Q2 guideline for linearity, range, accuracy, and precision. Comparison for both method UV and PhotoMetrix done by performing t-test, result shows that there is no significant difference between both method so PhotoMetrix can be used as alternative to UV for routine analysis of Hydroxychloroquine Sulphate.
 Keywords: Hydroxychloroquine Sulphate, Bromocresol green, Potassium Hydrogen Phthalate buffer, UV spectrophotometric, PhotoMetrix.