Method Development and Validation for Simultaneous Estimation of Olmesartan Medoxomil and Hydrochlorothiazide By RP-hPLC

Vidyadhara, S.; Sasidhar, R. L. C.; Rao, Ballipalli Venkateswara; Tejaswi, K.; Reshma, M. V.

doi:10.13005/ojc/300123

Cited by 9 publications

(5 citation statements)

References 4 publications

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“…The % CV for NDMA and NDEA for six replicate injections are calculated using excel, results for system suitability, precision at LOQ level, system precision, method precision, and intermediate precision are carried as per the procedure, the recovery studies for 50%, 100%, and 150% are by spiking method and recovery yield using the assay formulae, linearity constructed from LOQ level to 150% W.R.T the working standard, slope, and correlation calculated using excel sheets [36][37][38] (Fig. 9 and 10).…”

Section: Methodsmentioning

confidence: 99%

In Vitro Analytical Evaluation of Nitrosamine – A Carcinogenic Impurities in Olmesartan Medoximil by Gc MS/MS Method

Saradhi

Kumar

Reddy³

2020

Asian J Pharm Clin Res

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Objective: A simple and sensitive method development and validation for the simultaneous determination of the N-nitrosamine dimethylamine (NDMA) and N Nitrosamine diethylamine (NDEA) in Olmesartan medoxomil (OLM) API and formulations by a tandem mass spectrometer (GC-MS/MS). Methods: Gas chromatography with a programmed oven temperature controller, Elite Wax (30 m × 0.25 mm × 0.5 μm) column, Helium as carrier gas and hyphenated to the tandem mass spectrometer powered with triple quadrupole mass analyzer, and photomultiplier tube detector. The method was validated as per the United States Food and Drug Administration (USFDA) guidelines. Results: With the selected GC-MS/MS conditions, the NDMA and NDEA 0.08 μg/ml (80 ng/ml) and 0.16 μg/ml (160 ng/ml) injected and Rt. for NDMA 5.634 and NDEA 6.516 min, respectively. A linear/range lies in between 0.024 and 0.120 μg/ml and 0.048 and 0.240 μg/ml for NDMA and NDEA with r2 >0.99. The precision, accuracy, and system suitability are established as per USFDA and ICH guidelines, the sensitivity of NDMA limit of detection and limit of quantification 0.08, 0.024 and NDEA 0.16, 0.048. Conclusion: Other nitrosamine impurities are not involved in the determination of NDMA and NDEA in the OLM using GC-MS/MS and the method is simple, sensitive, rapid, accurate, and precise.

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Section: Methodsmentioning

confidence: 99%

In Vitro Analytical Evaluation of Nitrosamine – A Carcinogenic Impurities in Olmesartan Medoximil by Gc MS/MS Method

Saradhi

Kumar

Reddy³

2020

Asian J Pharm Clin Res

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“…The method was linear in the range of concentrations of 10-30 μg/ml, correlation coefficient was 0.999, LOD enalapril-0.16 μg/ml, LOQ enalapril-0.49 μg/ml. The developed method was successfully applied for the determination of enalapril maleate and hydrochlorothiazide in drugs [59].…”

Section: Methods Of Quantitative Determination Of Enalapril Maleate Imentioning

confidence: 99%

Analysis of Approaches to the Development and Validation of the Methods of Analysis of Some Active Pharmaceutical Ingredients From the Group of Angiotensin Converting Enzyme Inhibitors in Drugs and Biological Liquids

Logoyda¹

2019

Int J App Pharm

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The quantity of medication brought into the marketplace is growing each year. Analytical method development is increasingly being introduced into fundamental pharmaceutical research and pharmaceutical analysis practice, taking into account their high sensitivity, accuracy, specificity and expressiveness. Search criteria was analytical method development for medicines from group of ACE inhibitors. Literature survey has been done in range of years 1990-2018 to make the review updated and comprehensive and to show the new approacheches to the development of the methods of analysis ACE inhibitors. The sources were world recognized journals and key words used as filter were angiotensin-converting enzyme inhibitors, captopril, enalapril, method development, spectrophotometry, HPLC, UHPLC. The current review is created with an intended to focus on the advantage of HPLC. Literature survey revealed that a number of methods have been reported for estimation of ACE inhibitors individually or in combination with other drugs. However, there is very few analytical methods reported for the simultaneous analysis of these drugs in a combined dosage formulation by HPLC. In additional, analysis of approaches to the development of the methods of analysis of ACE inhibitors in drugs and biological liquids has been shown that HPLC is the most suitable method for analyses ACE inhibitors in substances, drugs, biological liquids to performe routine analysis of medicines, pharmacokinetic (bioequivalence in vivo), dissolution test for final dosages forms (bioequivalence in vitro, biowaiver procedure).

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“…The result formulation was reported in Table 6. Statistical analysis proves that the method is suitable for the analysis of OLME, AMLO, and HCTZ as bulk drug and in the pharmaceutical formulation without any interference from the excipients [26][27][28][29][30][31][32][33][34][35][36][37][38][39] .…”

Section: Preparation Of Standard Stock Solutionmentioning

confidence: 99%

Untitled

2020

IJPSR

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The endeavor of the present work is to develop a simple, economical, efficient, novel green analytical method for the estimation of Amlodipine besylate, Olmesartan medoxomil and Hydrochlorothiazide in pharmaceutical formulation. Quantification was carried out using an Inertsil CN-3.5 μm (4.6 ×250 mm) column, where the mobile phase consisting of 10 mm Phosphate buffer (pH 3.0) and Acetonitrile (40:60). The flow rate was 1.0 mL/min and the effluent was monitored at 262 nm. The observed linearity was in the range of 5-25 µg/ml for Amlodipine (AMLO), Hydrochlorothiazide (HCTZ) and Olmesartan medoxomil (OLME) with a correlation coefficient of 0.997, 0.999 and 0.999 respectively. The proposed method was validated as per ICH guidelines in terms of linearity, accuracy, precision, robustness, and specificity, the limit of detection and limit of quantification. The method has been applied to Amlodipine, Hydrochlorothiazide and Olmesartan formulation without the interference of excipients of the formulation. INTRODUCTION: Amlodipine Besylate: Amlodipine Besylate (2-[(2-Aminoethoxy) methyl]-4-(2-chlorophenyl)-1, 4dihydro-6-methyl-3, 5-pyridinedicarboxylic acid 3ethyl 5-methyl ester benzene sulfonate). Amlodipine is an L-type calcium channel blocker, which decreases the contraction of action and myosin fibers in the cardiac tissue by decreasing the supply of calcium ions. This results in a significant decrease in blood pressure 1, 4-8. The chemical structure was shown in Fig. 1.

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Method Development and Validation for Simultaneous Estimation of Olmesartan Medoxomil and Hydrochlorothiazide By RP-hPLC

Cited by 9 publications

References 4 publications

In Vitro Analytical Evaluation of Nitrosamine – A Carcinogenic Impurities in Olmesartan Medoximil by Gc MS/MS Method

In Vitro Analytical Evaluation of Nitrosamine – A Carcinogenic Impurities in Olmesartan Medoximil by Gc MS/MS Method

Analysis of Approaches to the Development and Validation of the Methods of Analysis of Some Active Pharmaceutical Ingredients From the Group of Angiotensin Converting Enzyme Inhibitors in Drugs and Biological Liquids

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