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101878

Development and validation of stability indicating rp-uplc assay method for the determination of lacosamide and quetiapine fumarate in bulk and tablet dosage forms

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Last updated: 22 Jan 2023

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Abstract

Validation of stability indicating RP-UPLC assay method for the determination of Lacosamide and Quetiapine fumarate in pharmaceutical products. This method has showed a high degree performance in separation and quantification of Lacosamide and Quetiapine even in the presence of its impurities. The separation was quite efficient on waters acquity BEH C18 column (50 mm×2.1 mm, 1.7 μm) having used the phosphate buffer pH 2.5 and acetonitrile in the ratio of 75:25 v/v with a flow rate of 0.2 mL/min. The detection was carried out at 210 nm and the elution run time was 5.0 min. The method was linear and found to be in the range between 0.0149 μg/mL-74.71μg/mL (r2=0.9999) and 0.0148 μg/mL-74.67 μg/mL (r2=0.9999) for Lacosamide and Quetiapine respectively. The limit of detection 0.0149μg/mL, 0.0148μg/mL and quantification 0.031 μg/mL, 0.030 μg/mL for Lacosamide and Quetiapine were determined respectively. The precision result of the method ‘% RSD' is less than 0.70 % and the recovery % of Lacosamide, Quetiapine is between 99.1 and 99.9. When the drug is subjected to different stress conditions, the consequential degradation products obtained could not interfere with Lacosamide and Quetiapine during the determination.

DOI

10.21608/bfpc.2019.101878

Keywords

Lacosamide, Quetiapine Fumarate, RP-UPLC, Stability indicating, validation

Authors

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Tene

Last Name

Sivaganesh

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Affiliation

Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam, Visakhapatnam District, 530003, India.+, Department of Analytical chemistry, Aurobindo Pharma Ltd, Pydibhimavaram, Srikakulam District, 532409, India.

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First Name

T.

Last Name

Rao

MiddleName

Siva

Affiliation

Department of Inorganic & Analytical Chemistry, Andhra University, Visakhapatnam, Visakhapatnam District, 530003, India.

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Orcid

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First Name

K.

Last Name

Ramasrinivas

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-

Affiliation

Department of Analytical chemistry, Aurobindo Pharma Ltd, Pydibhimavaram, Srikakulam District, 532409, India.

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First Name

U.

Last Name

SeshamRaju

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-

Affiliation

Department of Analytical chemistry, Aurobindo Pharma Ltd, Pydibhimavaram, Srikakulam District, 532409, India.

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Orcid

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First Name

Y.

Last Name

Shasikiran

MiddleName

M.

Affiliation

Department of Analytical chemistry, Aurobindo Pharma Ltd, Pydibhimavaram, Srikakulam District, 532409, India.

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City

-

Orcid

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First Name

G.

Last Name

Raja

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-

Affiliation

Department of Analytical chemistry, Aurobindo Pharma Ltd, Pydibhimavaram, Srikakulam District, 532409, India.

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Volume

57

Article Issue

2

Related Issue

15414

Issue Date

2019-12-01

Receive Date

2020-07-09

Publish Date

2019-12-01

Page Start

157

Page End

166

Print ISSN

1110-0931

Online ISSN

2090-9101

Link

https://bfpc.journals.ekb.eg/article_101878.html

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https://bfpc.journals.ekb.eg/service?article_code=101878

Order

6

Type

Original Article

Type Code

771

Publication Type

Journal

Publication Title

Bulletin of Faculty of Pharmacy, Cairo University

Publication Link

https://bfpc.journals.ekb.eg/

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Article

Created At

22 Jan 2023