71919

Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.

Article

Last updated: 01 Jan 2025

Subjects

-

Tags

Analytical chemistry

Abstract

The current work provides method development and validation of a rapid, robust, precise and accurate RP-HPLC and RP-UPLC for the assessment of Valsartan (VAL) in the presence of Nebivolol (NEB) or Amlodipine (AML) in their combined solid dosage form, following the ICH instructions. In RP-HPLC, Separation was achieved on an Inertsil column, (C18, 150 mm x 4.6 mm, 5μm) with (30:20:50 v/v%), mobile phase of (buffer pH 3.0: acetonitrile: methanol) in an isocratic mode with a flow rate 1.0 mL/min and using photodiode array (PDA) detection at 281 nm. However, in RP-UPLC, Mobile phase was phosphate buffer pH 3.0 and acetonitrile in a ratio of 55:45 v/v% at a flow rate 0.3 mL/min on an Eclipse Plus column, (C18, 1.8 µm, 50 mm × 2.1 mm), while detection at 240 nm on a PDA detector. Calibration curves were linear over the concentration ranges of (0.80-72.00,0.05-4.50) and (4.00-144.00, 0.125-4.50)µg/mL, for the assay and in-vitro drug release profile of (VAL, NEB) and (VAL, AML), respectively. In-Vitro dissolution studies revealed that not less than (NLT) 85% of the labeled amount of VAL and AML was released within 15 min and NLT 85% of the labeled amount of NEB was dissolved within 20 min from their fixed combination solid dosage forms.

DOI

10.21608/ejchem.2020.18176.2116

Keywords

Amlodipine, Nebivolol and Valsartan, Development, validation and dissolution, RP-HPLC and RP-UPLC

Authors

First Name

Abdelaziz

Last Name

Annadi

MiddleName

-

Affiliation

Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt.

Email

abdelaziz_annadi@yahoo.com

City

-

Orcid

-

First Name

Ragaa

Last Name

Shoheib

MiddleName

Elsheek

Affiliation

Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt.

Email

ragaaelsheikh@hotmail.com

City

-

Orcid

-

First Name

Ashraf

Last Name

Mohamed

MiddleName

-

Affiliation

Chemistry Department, Faculty of Science, Ain Shams University, Abbassia, Cairo, 11566, Egypt.

Email

aamohamd@hotmail.com

City

-

Orcid

-

Volume

63

Article Issue

8

Related Issue

10594

Issue Date

2020-08-01

Receive Date

2019-10-15

Publish Date

2020-08-01

Page Start

2,837

Page End

2,851

Print ISSN

0449-2285

Online ISSN

2357-0245

Link

https://ejchem.journals.ekb.eg/article_71919.html

Detail API

https://ejchem.journals.ekb.eg/service?article_code=71919

Order

4

Type

Original Article

Type Code

297

Publication Type

Journal

Publication Title

Egyptian Journal of Chemistry

Publication Link

https://ejchem.journals.ekb.eg/

MainTitle

Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.

Details

Type

Article

Created At

22 Jan 2023