SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF AMILORIDE HYDROCHLORIDE AND FUROSEMIDE IN A PHARMACEUTICAL DOSAGE FORM USING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

JAVED S  SHAIKH; Nutan N Rao

doi:10.22159/ajpcr.2018.v11i7.25783

Authors

JAVED S SHAIKH Department of Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra - 400 705, India.
Nutan N Rao Department of Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra - 400 705, India.

DOI:

https://doi.org/10.22159/ajpcr.2018.v11i7.25783

Keywords:

Amiloride hydrochloride, Furosemide, Reverse-phase high-performance liquid chromatography, Degradation, Validation, ICH

Abstract

Objective: The present study describes the stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of amiloride hydrochloride and furosemide in pharmaceutical dosage forms.

Methods: The proposed RP-HPLC method was developed using Shimadzu LC-2030 HPLC system equipped with UV detector, and chromatographic separation was carried on Shim-pack C18 (250 mmÃ—4.6 mm, 5 Î¼) column at a flow rate of 1 ml/min and the runtime was 4min. The mobile phase consisted of water and acetonitrile in the ratio of 35:65, and elements were scanned using a UV detector at 281 nm.

Results: The retention time of amiloride hydrochloride and furosemide was found to be 1.92 min and 3.14min, respectively. Linearity was found to be 12â€“28 ppm for amiloride hydrochloride and 96â€“224 ppm for furosemide, respectively. Limit of detection and limit of quantification for amiloride hydrochloride were 0.381 ppm and 1.156 ppm and for furosemide were 2.00 ppm and 6.068 ppm, respectively.

Conclusion: The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, humidity, photolytic, and thermal degradation, and the degraded products formed were resolved successfully from the samples.

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Author Biographies

JAVED S SHAIKH, Department of Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra - 400 705, India.

Department of Pharmaceutical Chemistry and Quality Assurance, Assistant Professor

Nutan N Rao, Department of Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra - 400 705, India.

Research Fellow (M Pharm)

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