SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF GRANISETRON HYDROCHLORIDE IN BULK AND INJECTIONSAbstract
The present UV Spectrophotometric and RP-HPLC method was simple, accurate, precise, specific, and sensitive. Spectrophotometric method was developed in water and very useful for analysis of bulk drug and injection formulation. RP-HPLC method was developed in Phosphate buffer (pH 3.0 adjusted with orthophosporic acid) and acetonitrile (70:30) using column HiQsil C18 column (250 × 4.6 mm; 5 μm). Flow Rate: 1.0 ml / min. The method was validated for the determination of granisetron hydrochloride in bulk and parenteral dosage form. The standard solution of granisetron hydrochloride in water showed maximum absorption at 301 nm with correlation, slope, and intercept 0.9998, 0.04198, and 0.01255, respectively and the percentage recovery of the formulation was 99.965% by UV spectrophotometry. By RP-HPLC, the % RSD of intraday and interday precision was 0.82% and 1.40 %, respectively. The % means recovery amount of Granisetron hydrochloride in 80 %, 100%, 120% was 94.3%, 94.9%, 95.2%, respectively, which reflect that the method was free from the interference of the impurities and other additives during the estimation of drug in the formulation. The proposed method can be successfully used for analysis of granisetron hydrochloride in marketed preparations. The results of analysis have been validated statistically and by recovery studies. This method was found suitable for quantitative and qualitative estimation of granisetron hydrochloride in bulk and parenteral dosage form.
P. B. Badhan *, S. S. Sonawane, A. V. Shelke and A. G. Jadhav
Department of Pharmaceutical Chemistry, Sandip Institute of Pharmaceutical Sciences, Mahiravani, Nashik, Maharashtra, India.
22 February 2020
25 May 2020
28 June 2020
01 February 2021