Abstract

A NOVEL VALIDATED UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF DOLUTEGRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Santhosh Illendula*, Rafiya Jabeen, Pilli Sony, Irfan Alam, CH.V. Suresh and K.N.V. Rao

ABSTRACT

A new simple, accurate, rapid, precise and reproducible spectrophotometric method for the quantitative estimation Dolutegravir in bulk form. The developed visible spectrophotometric method for the quantitative estimation of Dolutegravir is based on measurement of absorption at maximum wavelength 274 nm using with acetonitrile: Ammonium acetate buffer (50:50) as a solvent. The stock solution of Dolutegravir was prepared, and subsequent suitable dilution was prepared in diluent to obtained standard curve. The standard solution of Dolutegravir shows absorption maxima at 274 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 μg/ml with regression 0.999976 at 274 nm. The overall % recovery was found to be 99.22% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.5427 and 0.4479, respectively which is<2% hence proved that method is precise. The results of analysis have been validated as per International Conference  on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Dolutegravir in bulk form.

Keywords: Dolutegravir, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Acetonitrile, Ammonium acetate buffer, Accuracy, Precision.