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189844

HPLC/ELSD Determination and Validation of Alpha Lipoic Acid and Sucralose in Bulk and in Their Pharmaceutical Dosage Forms

Article

Last updated: 04 Jan 2025

Subjects

-

Tags

Medicinal chemistry.

Abstract

Accurate, sensitive, robust and direct isocratic Reversed Phase-HPLC methods, using Evaporative Light Scattering Detector, (ELSD), had been developed and fully validated for the detection and quantification of two non-chromophoric nutraceuticals; Alpha Lipoic Acid (ALA) and Sucralose (SUC). Chromatographic separation was achieved using C18 Zoprax, 5 μm, 15 cm column for both compounds. For ALA, mobile phase was composed of acetonitrile: 0.1 M acetic acid (60:40, v/v), adjusted at pH 2.5, with 0.6 mL/min flow rate. For SUC, acetonitrile: deionized water (70:30, v/v) with 1 mL/min flow rate was used. Temperatures of drift tube, column, and spray chamber have been set to be 40°C and 30°C respectively during both assays. All varying chromatographic parameters were studied carefully. ALA and SUC had eluted at 4.81±0.02 min and 1.70±0.01 min, respectively. The obtained exponential ELSD responses, for the two developed methods, were linearly modeled using logarithmic transformation. Good Linearities had been achieved over the concentration ranges of 100-750 ppm and 16-500 ppm for ALA and SUC estimation respectively. The suggested methods disclosed excellent precision and accuracy levels. All validation parameters were fulfilled according to the USP elements and ICH guidelines. Satisfactory percentages of recovery (>97%) resulted upon methods application for the assay of each dietary supplement in its pharmaceutical formulation. Comparative statistical study was conducted between the proposed HPLC/ELSD methods and the reported HPLC/UV method for ALA and reported HPTLC method for SUC. Student's t-tests and F-variance ratios for both methods had resulted in satisfactory values.

DOI

10.21608/jampr.2021.63273.1015

Keywords

Alpha lipoic acid, sucralose, HPLC, Evaporative light scattering detector, validation

Authors

First Name

Nourhan

Last Name

Abdelbarey

MiddleName

M.

Affiliation

Department of Pharmaceutical Analytical Chemistry , Faculty of Pharmacy , Pharos university , Alexandria

Email

nourhan.abdelbarey@pua.edu.eg

City

Alexandria

Orcid

-

First Name

Mokhtar

Last Name

Mabrouk

MiddleName

M.

Affiliation

Department of pharmaceutical analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt

Email

mokhtaribrahim50@yahoo.com

City

tanta

Orcid

-

First Name

Miranda

Last Name

Kamal

MiddleName

F.

Affiliation

Faculty of pharmacy, department of Pharmaceutical Analytical Chemistry ,Damanhour University, damanhour , Egypt

Email

mirandafawzy@yahoo.com

City

Damanhour

Orcid

-

Volume

2

Article Issue

2

Related Issue

27925

Issue Date

2021-09-01

Receive Date

2021-02-16

Publish Date

2021-04-07

Page Start

39

Page End

47

Online ISSN

2636-4158

Link

https://jampr.journals.ekb.eg/article_189844.html

Detail API

https://jampr.journals.ekb.eg/service?article_code=189844

Order

1

Type

Original Article

Type Code

855

Publication Type

Journal

Publication Title

Journal of Advanced Medical and Pharmaceutical Research

Publication Link

https://jampr.journals.ekb.eg/

MainTitle

HPLC/ELSD Determination and Validation of Alpha Lipoic Acid and Sucralose in Bulk and in Their Pharmaceutical Dosage Forms

Details

Type

Article

Created At

22 Jan 2023