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200495

Development and Validation of an RP-HPLC-UV Method for the Analysis of Drugs Used for Benign Prostatic Hyperplasia in Pharmaceutical Preparations

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Last updated: 28 Dec 2024

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Abstract

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) with UV detection method for the simultaneous estimation of alfuzocin hydrochloride and finasteride in tablets which are used in benign prostatic hyperplasia therapy. The separation and quantification was achieved by Shim pack XR ODS (250 mm x 4.6 mm, 5 μm id) in isocratic mode, with mobile phase consisting of acetonitrile: water with 1 % Triethyl amine (TEA) (pH 7.0) (75:25 v/v) at a flow rate of 1 ml/min. Spectrophotometric detection was performed at a wavelength of 223 nm. The retention time of alfuzocin hydrochloride and finasteride was found to be 2.90 and 4.46 min, respectively. The developed method was validated according to ICH guidelines Q2 (R1). The method was validated for linearity, accuracy, and precision. Linearity for alfuzocin hydrochloride and finasteride were in the range 4-12 μg/ml for both drugs. The relative standard deviation values for intermediate precision studies were <1%. Statistical analysis of the data showed that the method was precise, accurate, reproducible and selective for the analysis of alfuzocin hydrochloride and finasteride. The method was successfully employed for the determination of alfuzocin hydrochloride and finasteride in commercially available tablet dosage form.

DOI

10.18576/jpac/030202

Keywords

Alfuzocin hydrochloride, Finasteride, RP-HPLC, validation, Tablet

Authors

First Name

Dhara

Last Name

Patel

MiddleName

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Affiliation

Department of Quality Assurance, Pioneer Pharmacy Degree College, Vadodara 390019, Gujarat, India.

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First Name

Pinal

Last Name

Patel

MiddleName

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Affiliation

Department of Quality Assurance, Pioneer Pharmacy Degree College, Vadodara 390019, Gujarat, India.

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City

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Orcid

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First Name

Sharav

Last Name

Desai

MiddleName

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Affiliation

Department of Pharmaceutical Microbiology and biotechnology, Pioneer Pharmacy Degree College, Vadodara -390019, Gujarat, India.

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City

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Orcid

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First Name

Dhananjay

Last Name

Meshram

MiddleName

-

Affiliation

Department of Quality Assurance, Pioneer Pharmacy Degree College, Vadodara 390019, Gujarat, India.

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Volume

2

Article Issue

1

Related Issue

28202

Issue Date

2016-01-01

Receive Date

2021-10-20

Publish Date

2016-01-01

Page Start

47

Page End

52

Online ISSN

2357-0210

Link

https://jpac.journals.ekb.eg/article_200495.html

Detail API

https://jpac.journals.ekb.eg/service?article_code=200495

Order

200,495

Type

Original Article

Type Code

2,018

Publication Type

Journal

Publication Title

Journal of Pharmaceutical and Applied Chemistry

Publication Link

https://jpac.journals.ekb.eg/

MainTitle

Development and Validation of an RP-HPLC-UV Method for the Analysis of Drugs Used for Benign Prostatic Hyperplasia in Pharmaceutical Preparations

Details

Type

Article

Created At

23 Jan 2023