Novel extractive colorimetric and UV spectrophotometric estimation of etizolam in bulk and tablet by forming ion association complex with methyl orange and bromocresol green

Abstract

A novel, sensitive, and rapid UV spectrophotometric and colorimetric method was developed for estimation of etizolam (ETZ) in bulk and tablet. The UV spectrophotometric method (method I) is based on quantitative estimation of ETZ using 0.1N NaOH as the solvent which exhibits maximal absorption at 378 nm. Colorimetric methods (method II and III) were based on the formation of color complex in association with ions between basic nitrogen of the drug with methyl orange (MO) and bromocresol green (BCG) in acidic medium. The formed color complexes were quantitatively extracted with chloroform and measured at 509 nm for Drug–MO complex and at 442 nm for Drug–BCG complex, respectively. Beer's law was obeyed over the linear ranges 2–16 µg/ml (method I), 5–45 µg/ml (method II), and 2–20 µg/ml (method III). The correlation coefficient (r²) for ETZ was 0.999, 0.997, and 0.998 for method I, II, and III, respectively. All methods were successfully applied for the assay of the drug in tablet. The % purity was found to be 98.52 (method I), 98.72 (method II), and 99.18 (method III). These developed methods were fully validated with % relative standard deviation (RSD) for accuracy less than 2 for all methods. The % RSD of the intra-day and inter-day variations was found to be less than 2%. The limit of detection and quantitation were as follows: 0.108 µg/ml and 0.327 µg/ml (method I), 0.24 µg/ml and 0.75 µg/ml (method II), 0.1 µg/ml and 0.5 µg/ml (method III) indicating marked method sensitivity. Empirical evidence from all three methods concludes that developed methods are simple, sensitive, and reliably validated for useful routine quality control analysis of ETZ.

Keywords:

• etizolam
• bromocresol green
• methyl orange
• UV visible spectrophotometry
• colorimetry

Acknowledgments

The authors would like to thank Cadila Pharmaceuticals, Vapi, Gujarat, India for providing ETZ as a gift sample. The authors also extend their thanks to the management, Vaageswari College of Pharmacy, Karimnagar, AP, India for providing financial help for purchasing chemicals, and supplying laboratory and instrumental facility.

Disclosure statement

No potential conflict of interest was reported by the authors.