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

Learn More →

Rapid Analytical Technique for the Quantification of Specified and Unspecified Impurities Present in Amlodipine besylate and Olmesartan medoxomil Fixed Dose Combination Drug Product Using Ethylene-Bridged RP-UPLC Column

Rapid Analytical Technique for the Quantification of Specified and Unspecified Impurities Present... AbstractThe current research work describes about well thought out development and validation of liquid chromatographic method for simultaneous determination of specified and unspecified impurities present in Amlodipine besylate and Olmesartan medoxomil fixed dose combination drug product. Reverse phase-Ultra Performance liquid chromatography (RP-UPLC) technique has been chosen for faster separation between impurities. Effective and rapid separation between impurities at satisfactory level is achieved using Acquity UPLC BEH C8, 100 mm length x 2.1 mm ID column with 1.7 mm particle size. Flow gradient elution mode was kept using 0.1% orthophosphoric acid in water as Mobile phase A and acetonitrile as Mobile phase B. Initial flow rate was kept at 0.5 mL.min-1 followed by gradual increase to 0.7 mL.min-1 to elute non polar eluents from Amlodipine besylate and Olmesartan medoxomil with a monitoring wavelength of 237 nm. Developed method was successfully validated as per pharmacopeia and general recommendation given for validation study as specified in ICH for specificity (stress study), precision, accuracy, linearity, determination of Limit of Detection (LOD) & Limit of Quantification (LOQ), solution stability and robustness. The developed and validated method requires less consumption of solvents with shorter run time of 15 minutes results in a rapid, precise, sensitive, cost and time effective method for the quantitative determination of Amlodipine besylate and Olmesartan medoxomil impurities in Amlodipine besylate and Olmesartan medoxomil tablets dosage forms helping to improve quality control and to assure therapeutic efficacy. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Rapid Analytical Technique for the Quantification of Specified and Unspecified Impurities Present in Amlodipine besylate and Olmesartan medoxomil Fixed Dose Combination Drug Product Using Ethylene-Bridged RP-UPLC Column

Download PDF

Rapid Analytical Technique for the Quantification of Specified and Unspecified Impurities Present in Amlodipine besylate and Olmesartan medoxomil Fixed Dose Combination Drug Product Using Ethylene-Bridged RP-UPLC Column

Abstract

AbstractThe current research work describes about well thought out development and validation of liquid chromatographic method for simultaneous determination of specified and unspecified impurities present in Amlodipine besylate and Olmesartan medoxomil fixed dose combination drug product. Reverse phase-Ultra Performance liquid chromatography (RP-UPLC) technique has been chosen for faster separation between impurities. Effective and rapid separation between impurities at satisfactory level is...
Loading next page...
 
/lp/taylor-francis/rapid-analytical-technique-for-the-quantification-of-specified-and-DCoTPy8kK8
Publisher
Taylor & Francis
Copyright
© 2016 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2016.1253500
Publisher site
See Article on Publisher Site

Abstract

AbstractThe current research work describes about well thought out development and validation of liquid chromatographic method for simultaneous determination of specified and unspecified impurities present in Amlodipine besylate and Olmesartan medoxomil fixed dose combination drug product. Reverse phase-Ultra Performance liquid chromatography (RP-UPLC) technique has been chosen for faster separation between impurities. Effective and rapid separation between impurities at satisfactory level is achieved using Acquity UPLC BEH C8, 100 mm length x 2.1 mm ID column with 1.7 mm particle size. Flow gradient elution mode was kept using 0.1% orthophosphoric acid in water as Mobile phase A and acetonitrile as Mobile phase B. Initial flow rate was kept at 0.5 mL.min-1 followed by gradual increase to 0.7 mL.min-1 to elute non polar eluents from Amlodipine besylate and Olmesartan medoxomil with a monitoring wavelength of 237 nm. Developed method was successfully validated as per pharmacopeia and general recommendation given for validation study as specified in ICH for specificity (stress study), precision, accuracy, linearity, determination of Limit of Detection (LOD) & Limit of Quantification (LOQ), solution stability and robustness. The developed and validated method requires less consumption of solvents with shorter run time of 15 minutes results in a rapid, precise, sensitive, cost and time effective method for the quantitative determination of Amlodipine besylate and Olmesartan medoxomil impurities in Amlodipine besylate and Olmesartan medoxomil tablets dosage forms helping to improve quality control and to assure therapeutic efficacy.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Nov 1, 2016

Keywords: Stability Indicating; Amlodipine besylate; Olmesartan medoxomil; RP-UPLC and Stress study

References

  • Pharmacokinetic and pharmacodynamic profiles of a fixed-dose combination of olmesartan medoxomil and amlodipine in healthy Chinese males and females
  • Olmesartan medoxomil/amlodipine/hydrochlorothiazide: fixed-dose combination in hypertension
  • Development and validation of spectrophotometric methods for simultaneous estimation of Amlodipine Besylate and Olmesartan Medoxomil in combined dosage form
  • Spectrophotometric simultaneous determination of olmesartan medoxomil and amlodipine besylate in combined tablet dosage form
  • Simultaneous spectrophotometric estimation of Olmesartan medoxomil, Amlodipine besylate and Hydrochlorothiazide in pharmaceutical dosage form
  • Spectrophotometric methods for simultaneous determination of ternary mixture of amlodipine besylate, olmesartan medoxomil and hydrochlorothiazide
  • Application of smart spectrophotometric methods and artificial neural network for the simultaneous quantitation of olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide in their combined pharmaceutical dosage form
  • High performance liquid chromatographic method for determination of Amlodipine besilate and Olmesartan medoxomil in tablet dosage form
  • RP-HPLC method for simultaneous estimation of amlodipine besylate and olmesartan medoxomil from tablet
  • Simultaneous estimation of amlodipine besylate and olmesartan medoxomil drug formulations by HPLC and UVspectrophotometric methods
  • Stability Indicating LC Method For the Simultaneous Determination of Amlodipine and Olmesartan in Dosage By
  • Development and validation of a rapid RP-HPLC method for the determination of amlodipine besylate and olmesartan medoxomil in their combined tablet formulation
  • RP-HPLC method development and validation for simultaneous estimation of amlodipine besylate, olmesartan medoxomil and hydrochlorthiazide in combined tablet dosage forms
  • Development and validation of stability indicating HPLC assay method for simultaneous determination of amlodipine besylate, olmesartan medoxomil and hydrochlorothiazide in tablet formulation
  • Development and validation of RP-HPLC-PDA method for the simultaneous estimation of hydrochlorothiazide, amlodipine besylate and olmesartan medoxomil in bulk and pharmaceutical dosage forms
  • Simultaneous determination of Olmesartan, Amlodipine Besylate and Hydrochlorothiazide in tablet dosage form by using stability-indicating HPLC method
  • Simultaneous determination and validation of olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide in combined tablet dosage form using RP-HPLC method
  • Stability-Indicating Method for Simultaneous Estimation of Olmesartan Medoxomile, Amlodipine Besylate and Hydrochlorothiazide by RP-HPLC in Tablet Dosage Form
  • Simultaneous quantitation of olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide in pharmaceutical dosage form by using HPLC
  • Development and validation of stability indicating HPLC assay method for simultaneous determination of amlodipine besylate, olmesartan medoxomil and hydrochlorothiazide in tablet formulation
  • A new and rapid analytical method development & validation for simultaneous estimation of hydrochlorothiazide, amlodipine & olmesartan in tablet dosage form by using RP-HPLC