Delving into the Latest Updates on Felodipine/Ramipril with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ramipril/felodipine, Tazko, Unimax

+ [2]

Target

ACE x VDCCs

Action

inhibitors, blockers

Mechanism

ACE inhibitors(Angiotensin-converting enzyme inhibitors), VDCCs blockers(Voltage-gated calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Essential Hypertension

Inactive Indication-

Originator Organization

AstraZeneca PLC

Active Organization

AstraZeneca PLC

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Sweden (07 Apr 1998),

Essential Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC41H51Cl2N3O9

InChIKeyZLIWVWWYMAJKIU-IKZVEOHFSA-N

CAS Registry119920-75-1

A rapid and sensitive High Performance Liquid Chromatography (HPLC) method has been developed and validated as per ICH guideline for simultaneous determination of ramipril and felodipine binary mixture. Chromatographic separation was achieved on a Hyperchom C18 column (250 × 4.6 mm i.d., 5 μm) using an isocratic mobile phase of potassium di-hydrogen phosphate (pH = 3.4): methanol: acetonitrile in the ratio 15:15:70 (v:v:v). The flow rate was 1.5 mL/min, temperature of the column was maintained at 30 °C and detection was made at 210 nm. Linearity studies indicated that the drugs obey Beer’s law over the range of 10-80 μg/mL for ramipril and 5-80 μg/mL for felodipine. The proposed method is precise, accurate, linear and robust. The short retention time allows the analysis of a large number of samples in a short period of time and, therefore, considered to be cost-effective that can be used for routine analysis of both drugs in the pharmaceutical industry.

01 Mar 2017·Journal of Chromatography BQ3 · MEDICINE

Ultrasound assisted dispersive liquid-liquid microextraction coupled with high performance liquid chromatography designated for bioavailability studies of felodipine combinations in rat plasma

Q3 · MEDICINE

Article

Author: Sameh Ahmed ; Marwa Fathy Bakr Ali ; Noha N. Atia

Felodipine (FLD), a calcium channel antagonist, is commonly prescribed for the treatment of hypertension either with Metoprolol (MET) or Ramipril (RAM) in two different drug combinations. FLD has high plasma protein binding ability affecting its extraction recoveries from plasma samples. Hence, a specific ultrasound assisted dispersive liquid-liquid microextraction (UA-DLLME) method coupled with HPLC using photodiode array detector was developed and validated for the simultaneous determination of FLD, MET and RAM in rat plasma after oral administration of these combinations. The factors affecting UA-DLLME were carefully optimized. In this study, UA-DLLME method could provide simple and efficient plasma extraction procedures with superior recovery results. Under optimum condition, all target drugs were separated within 13min. The validation procedures was carried out in agreement with US-FDA guidelines and shown to be suitable for anticipated purposes. Linear calibration ranges were obtained in the range 0.05-2.0μgmL^-1 for FLD and MET and 0.1-2.0μgmL^-1 for RAM with detection limits of 0.013-0.031μgmL^-1 for all the studied drug combinations. The%RSD for inter-day and intra-day precisions was in range of 0.63-3.85% and the accuracy results were in the range of 92.13-100.5%. The validated UA-DLLME-HPLC method was successfully applied for the bioavailability studies of FLD, MET and RAM. The pharmacokinetic parameters were calculated for all the investigated drugs in rats after single-dose administrations of two different drug combinations. Although FLD was bioequivalent in the two formulations, a small increase in plasma levels of MET and RAM was found in the presence of FLD.

01 Apr 2008·Analytical Letters

Comparative Spectrophotometric, Spectrofluorometric, and High‐performance Liquid Chromatographic Study for the Quantitative Determination of the Binary Mixture Felodipine and Ramipril in Pharmaceutical Formulations

Author: Fawzy A. El Yazbi ; Nada M. Sonji ; Ghassan M. Sonji ; Mohamad E. Mahrous ; Hassan H. Hammud

Two-component mixtures of felodipine (FLD) and ramipril (RMP) were assayed by derivative UV spectrophotometry, spectrofluorometry, and high performance liquid chromatog. (HPLC).The spectrophotometric methods included a zero-crossing first- and second-order derivative procedure and a derivative compensation technique for the determination of binary mixtures with overlapping spectra.The spectrofluorometric method was based on first- and second-order derivatives of the emission spectra (zero-crossing point).Results from these methods were compared with those obtained by an exclusively developed isocratic reversed phase HPLC method.A reversed-phase Adsorbosil DS anal. column, with MeOH-acetonitrile-water (50:30:20, volume/volume) mobile phase at a flow rate of 1.5 mL/min, was used with a UV detector.The temperature was set at 25°.Results obtained by the spectrophotometric and spectrofluorometric methods were comparable to those obtained by the HPLC method, as far as anal. of variance (ANOVA) test results were concerned.It is concluded that the developed methods are equally accurate, sensitive, and precise; with direct and simple application to pharmaceutical formulations of felodipine and ramipril combination, without interference from common pharmaceutical adjuvants.

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