Abstract

DEVELOPEMENT ANALYTICAL AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMILORIDE HYDROCHLORIDEAND FUROSEMIDE AS API IN THEIR COMBINED TABLET DOSAGE FORM

Dr. Rashmi Kumari*, Dr. Vachaspati Dubey, Dr. Afroze Alam, S. N. Narayan Singh and Ruchi Singh

ABSTRACT

The simple, sensitive,accurate, precise,rapid and economical reverse phase high performance liquid chromatography method for the simultaneous estimation of Amiloride Hydrochloride and Furosemide in combined dosage form. This method was developed using an Instil C18(length-250mm*4.6mm) particle size -5μm column with a mobile phase consisting of acetonitrile:phosphate buffer (50:50v/v )pH 3±0.05 adjusted by o-phosphoric acid at a flow rate 1ml/min and run for 15 min detection was carried out at 283nm. The retension time for Amiloride Hydrochloride and Furosemide was found to be 10.004min and 3.040 min respectively. This method was linear in the range of 20- 200 μg and 10-100 μg/ml Furosemide and Amiloride Hydrochloride respectively. The correlation coefficient were 0.99925 for Amiloride Hydrochloride and 0.9999 for Furosemide. This method has been validated as per ICH guideline and applied for estimation of Amiloride Hydrochloride and Furosemide in commercially available tablet Dosage form.

Keywords: Amiloride, Furosemide, ICH, Tablet, RP-HPLC,Validation.