Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Analytical Method Development and Validation of a Dissolution Method for Aliskiren Hemifumarate and Hydrochlorthiazide in Bulk and in Combined Tablet Dosage From by UPLC

Analytical Method Development and Validation of a Dissolution Method for Aliskiren Hemifumarate... AbstractIn the present analytical study a rapid, robust and specific UPLC method has been developed and validated for Aliskiren hemifumarate and Hydrochlorothiazide in bulk and in combined tablet dosage form and it was applied to the dissolution study of Aliskiren hemifumarate and Hydrochlorthiazide. The separation was carried out on acquality UPLC HSS T3 100 mm×2.1, 1.8 μ column, using the mobile phase containing 0.1% Trifluoro acetic acid in water : Acetonitrile in the ratio of (75:25% v/ v) and at a flow rate of 0.4 ml / min and column temperature of 30°C. The UV detection was performed at 275 nm. The method developed for Aliskiren hemifumarate and Hydrochlorthiazide was found to be linear in the concentration range of 80 - 480 μg/ ml and 6 - 40 μg/ ml and correlation coefficient was found to be 0.9999 for both drugs. In accuracy the % recovery for Aliskiren hemifumarate and Hydrochlorthiazide was found to be 98.39 - 100.86% and 98.40 - 99.67%, respectively. The method was validated as per ICH guidelines. All the validation parameters were within the acceptance range. The development method can be successfully employed for the routine analysis of Aliskiren hemifumarate and Hydrochlorthiazide. Also the method was applied for the simultaneous estimation of Aliskiren hemifumarate and Hydrochlorthiazide in the sample collected from dissolution studies. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Analytical Method Development and Validation of a Dissolution Method for Aliskiren Hemifumarate and Hydrochlorthiazide in Bulk and in Combined Tablet Dosage From by UPLC

Download PDF

Analytical Method Development and Validation of a Dissolution Method for Aliskiren Hemifumarate and Hydrochlorthiazide in Bulk and in Combined Tablet Dosage From by UPLC

Abstract

AbstractIn the present analytical study a rapid, robust and specific UPLC method has been developed and validated for Aliskiren hemifumarate and Hydrochlorothiazide in bulk and in combined tablet dosage form and it was applied to the dissolution study of Aliskiren hemifumarate and Hydrochlorthiazide. The separation was carried out on acquality UPLC HSS T3 100 mm×2.1, 1.8 μ column, using the mobile phase containing 0.1% Trifluoro acetic acid in water : Acetonitrile in the ratio of...
Loading next page...
 
/lp/taylor-francis/analytical-method-development-and-validation-of-a-dissolution-method-n1ts2CpfRM
Publisher
Taylor & Francis
Copyright
© 2017 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2017.1298464
Publisher site
See Article on Publisher Site

Abstract

AbstractIn the present analytical study a rapid, robust and specific UPLC method has been developed and validated for Aliskiren hemifumarate and Hydrochlorothiazide in bulk and in combined tablet dosage form and it was applied to the dissolution study of Aliskiren hemifumarate and Hydrochlorthiazide. The separation was carried out on acquality UPLC HSS T3 100 mm×2.1, 1.8 μ column, using the mobile phase containing 0.1% Trifluoro acetic acid in water : Acetonitrile in the ratio of (75:25% v/ v) and at a flow rate of 0.4 ml / min and column temperature of 30°C. The UV detection was performed at 275 nm. The method developed for Aliskiren hemifumarate and Hydrochlorthiazide was found to be linear in the concentration range of 80 - 480 μg/ ml and 6 - 40 μg/ ml and correlation coefficient was found to be 0.9999 for both drugs. In accuracy the % recovery for Aliskiren hemifumarate and Hydrochlorthiazide was found to be 98.39 - 100.86% and 98.40 - 99.67%, respectively. The method was validated as per ICH guidelines. All the validation parameters were within the acceptance range. The development method can be successfully employed for the routine analysis of Aliskiren hemifumarate and Hydrochlorthiazide. Also the method was applied for the simultaneous estimation of Aliskiren hemifumarate and Hydrochlorthiazide in the sample collected from dissolution studies.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Jan 2, 2017

Keywords: Aliskiren hemifumarate; Hydrochlorthiazide; Dissolution study; UPLC; Validation

References

  • Simultaneous Determination of Aliskiren and Hydrochlo-rothiazide from their Pharmaceutical Preparations Using a Validated Stability-Indicating MEKC Method
  • Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma
  • Simultaneous Analysis of Aliskiren and Hydrochlorothiazide in Pharmaceutical Preparations and Spiked Human Plasma by HPTLC
  • Quantitative Simultaneous Determination of Amilodipine, Valsartan and Hydrochlorthiazide in “Exoforgehct” Tablets Using High Performance Liquid Chromatography and Thin Layer Chromatography
  • A Liquid Chromatography/Tandem Mass Spectrometry Method for the Simultaneous Quantification of Valsartan and Hydrochlorothiazide in Human Plasma
  • Spectroflourimetry Determination of Aliskiren in Tablets and Spiked Human Plasma through Derivatization with Dansyl Chloride
  • A Validated LC Method for the Determination of the Enantiomeric Purity of Aliskiren Hemifumarate in Bulk Drug Samples
  • RP-HPLC Method for Simultaneous Estimation of Telmisartan and Hydrochlorothiazide in Tablet Dosage Form
  • Method Development and Validation for Simultaneous Estimation of Aliskiren and Enalapril in Bulk and Synthetic Mixture by Reversed Phase High Performance Liquid Chromatographic Method
  • Stability indicating RP-HPLC method Development and Validation for Simultaneous Estimation of Aliskiren, Amlodipine and Hydrochlorthiazide in Tablet Dosage Form