Abstract

ANALYTICAL METHOD AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DROTAVARINE HYDROCHLORIDEAND NIMASULIDE AS API IN SYNTHETIC MIXTURE BY RP-HPLC METHOD AND UV-VISIBLE SPECTROSCOPY

Dr. Rashmi Kumari*, Dr. Vachaspati Dubey, Dr. Afroze Alam and Singh Nadkar and Narayan Singh

Abstract

A novel approach was develop and validate by rapid phase high performance liquid chromatography method for the simultaneous estimation of Drotavarine Hydrochloride and Nimasuide in active pharmaceutical ingradient (API) in synthetic mixture. This study describe the Simple, rapid, presice and accurate RP-HPLC method for simultaneous estimation in tablate dosage form. The separation were achived on Nucleosil (length-250mm*4.6mm) particle size -5μm column with an isocratic mixture of methanol and acetonitrile 50:50, pH adjusted to and flow rate 0.6ml/minand run time 10 min and UV detection at 298.5 nm. The retension time for Drotavarine Hydrochloride and Nimasuide was 6.28 min and 8.60 min respectively. This method was linear in the range of 2-20 μg and 5-40 μg/ml Drotavarine Hydrochloride and Nimasuide. The correlation coefficient were 0.9990 for Drotavarine Hydrochloride and 0.9980 for Nimusolide. This method has been validated as per ICH guideline and applied for estimation of Drotavarine Hydrochloride and Nimasuide in commercially available tablet Dosage form.

Keywords: Drotaverine, Nimesulide, ICH, Tablet.