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300773

UTILIZATION OF THE STABILITY-INDICATING RP-HPLC METHOD FOR DIETRY SUPPLEMENT CALCIUM OROTATE QUANTIFICATION IN CAPSULE DOSAGE FORM

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Last updated: 04 Jan 2025

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Abstract

A rapid, accurate, and precise HPLC approach for quantifying calcium orotate in capsule dosage form was developed and validated. As optimum conditions for analysis, a C8 column (250 mm x 4.6 mm, 5μ) was used as the stationary phase, with a mobile phase of 65:35 v/v acetonitrile and 25 mM potassium dihydrogen phosphate buffer (pH 4.7) at a flow rate 1 ml/min and detected at 254 nm. The method showed a 0.999 correlation and an excellent linear response throughout a concentration range of 15–90 μg/ml. Retention lasted for 3.186 minutes. Validation of the method done as per the requiremnts of ICH and  subjected to oxidation, photolysis, heat, acid, alkali hydrolysis, and water stress. Degradation byproducts did not affect the ability to detect calcium orotate, hence the approach is stability indicating. The approach may be used to determine calcium orotate in pharmaceutical capsule dose form since the findings of the research were within the parameters of ICH standards.

DOI

10.21608/bfsa.2023.300773

Keywords

Calcium orotate, HPLC, Stability-indicating

Authors

First Name

Swathi

Last Name

Koduru

MiddleName

-

Affiliation

Department of Pharmaceutical Analysis, Bojjam Narasimhlu College of Pharmacy for Women, Vinay Nagar, Saidabad, Hyderabad – 500059, Telangana, India

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Orcid

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First Name

Hemant

Last Name

Kumar T

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-

Affiliation

Department of Pharmaceutical Technology, NSHM Institute of Health Sciences, Kolkata, West Bengal 700053, India

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-

Orcid

-

First Name

Chaitanya

Last Name

Mitta

MiddleName

-

Affiliation

Department of Pharmaceutical Analysis, Bojjam Narasimhlu College of Pharmacy for Women, Vinay Nagar, Saidabad, Hyderabad – 500059, Telangana, India

Email

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City

-

Orcid

-

First Name

Swathi

Last Name

Kalepu

MiddleName

-

Affiliation

Department of Pharmaceutical Chemistry, Bojjam Narasimhlu College of Pharmacy for Women, Vinay Nagar, Saidabad, Hyderabad – 500059, Telangana, India

Email

-

City

-

Orcid

-

First Name

Ravindar

Last Name

Bairam

MiddleName

-

Affiliation

Department of Pharmaceutical Analysis, Srikrupa Institute of Pharmaceutical Sciences, Velikatta, Siddipet-502277, Telangana , India

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Orcid

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Volume

46

Article Issue

1

Related Issue

41495

Issue Date

2023-06-01

Receive Date

2022-09-20

Publish Date

2023-06-01

Page Start

141

Page End

156

Print ISSN

1110-0052

Online ISSN

3009-7703

Article File

BFSA_Volume 46_Issue 1_Pages 141-156.pdf

PDF . 1.1MB

Link

https://bpsa.journals.ekb.eg/article_300773.html

Detail API

https://bpsa.journals.ekb.eg/service?article_code=300773

Order

300,773

Type

Original Article

Type Code

1,096

Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

https://bpsa.journals.ekb.eg/

MainTitle

UTILIZATION OF THE STABILITY-INDICATING RP-HPLC METHOD FOR DIETRY SUPPLEMENT CALCIUM OROTATE QUANTIFICATION IN CAPSULE DOSAGE FORM

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Article

Created At

25 Dec 2024