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187912

Development and Validation of HPLC Method for Quantification of Daclatasvir in Pure and Solid Dosage Form

Article

Last updated: 22 Jan 2023

Subjects

-

Tags

Pharmaceutical Chemistry

Abstract

Daclatasvir is a novel and highly selective NS5A replication inhibitor of HCV. It is stated to offer the potential for interferon free treatment when used in combination with another direct acting antivirals. The current project is aimed to develop and validate an easy to perform, precise, fast and accurate reverse phase HPLC method for Daclatasvir in the solid dosage form by wielding UV detector, in accordance with ICH Q2 (R1) guidelines. The process was carried out for daclatasvir, utilizing C-18 column (25 cm length, 4.6 mm internal diameter, and 5 µm particle size) in isocratic mode, with mobile phase comprising of acetonitrile and phosphate buffer (40:60 v/v). The flow rate was 1 mL/min and the detection wavelength examined out by UV detector was 304 nm. The retention time for daclatasvir was 3.0 ± 0.1 min. RSD (0.65 %), theoretical plates (1118117) and tailing factor (1) complied within acceptable certified limits. The developed method showed the linearity within a range (1 – 5 µg/mL). The accuracy of the developed method was figured out by recovery analysis and it was 99 %. The precision analysis i.e. interday (0.0.790937 %), intraday (0.364517 %) and repeatability (0.229167 %), were within the acceptance criteria. All the validation parameters were within the acceptable limits. The sample solutions of daclatasvir tablets (Dacriva, 60 mg) developed and correlated its chromatograms with working standard solution and perceived the percentage purity of daclatasvir in the tablet, found within recommended acceptable limit (90 – 110 %). It is concluded that the HPLC method is sensitive, stable, rapid and reliable. It can be deployed for the quantification of daclatasvir of standard and brands available in market in the solid dosage form in the pharmaceutical industry.

DOI

10.21608/ejchem.2021.80600.3994

Keywords

NP HPLC, Daclatasvir, Assay, HPLC, quantification, validation

Authors

First Name

Nida

Last Name

Saeed

MiddleName

-

Affiliation

Punjab University College of Pharmacy, University of the Punjab

Email

nida.saeed96@gmail.com

City

Lahore

Orcid

-

First Name

Muhammad Shaharyar

Last Name

Afridi

MiddleName

Khan

Affiliation

H#2, St.#1 Behind Old Ice Factory Fateh Garh Road Gulshan Park Lalpul Mughalpura

Email

shaharyar_khan45@live.com

City

Lahore

Orcid

-

First Name

Abida

Last Name

Latif

MiddleName

-

Affiliation

Punjab University College of Pharmacy, University of the Punjab

Email

abidalatif43@yahoo.com

City

Lahore

Orcid

-

First Name

Hafiz Hanzalah

Last Name

Fahham

MiddleName

-

Affiliation

Punjab University College of Pharmacy, University of the Punjab

Email

hanzalahfahham123@gmail.com

City

Lahore

Orcid

-

First Name

Itzaz

Last Name

Aslam

MiddleName

-

Affiliation

Department of Pharmacy, University of Karachi, Karachi – 75270, Pakistan

Email

itimughal98@yahoo.com

City

-

Orcid

-

First Name

Muhammad

Last Name

Mazhar

MiddleName

-

Affiliation

Punjab University College of Pharmacy, University of the Punjab

Email

shaharyarkhan45@yahoo.com

City

Lahore

Orcid

-

First Name

Muhammad Shahbaz

Last Name

Afridi

MiddleName

Khan

Affiliation

Punjab University College of Pharmacy, University of the Punjab

Email

sk7991178@gmail.com

City

Lahore

Orcid

-

Volume

65

Article Issue

2

Related Issue

28751

Issue Date

2022-02-01

Receive Date

2021-06-14

Publish Date

2022-02-01

Page Start

81

Page End

91

Print ISSN

0449-2285

Online ISSN

2357-0245

Link

https://ejchem.journals.ekb.eg/article_187912.html

Detail API

https://ejchem.journals.ekb.eg/service?article_code=187912

Order

10

Type

Original Article

Type Code

297

Publication Type

Journal

Publication Title

Egyptian Journal of Chemistry

Publication Link

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

MainTitle

-

Details

Type

Article

Created At

22 Jan 2023