Beyond Use Date (BUD) Determination of Ambroxol Hydrochloride Syrup by High-Performance Liquid Chromatography – UV/VIS Detector

Catur Jatmika; Raditya Iswandana; Indah Dewi Lestari

doi:10.7454/psr.v10i1.1289

Beyond Use Date (BUD) Determination of Ambroxol Hydrochloride Syrup by High-Performance Liquid Chromatography – UV/VIS Detector

Catur Jatmika, Raditya Iswandana, Indah Dewi Lestari

Department of Pharmacy

Research output: Contribution to journal › Article › peer-review

Abstract

Ambroxol HCl is a mucolytic agent often used to treat respiratory disorders associated with excess mucus secretion. This study aims to determine the beyond-use date (BUD) of ambroxol HCl syrup on the market based on analysis of the decrease in drug content using High-Performance Liquid Chromatography (HPLC) – UV/Vis detector. The HPLC conditions were reversed-phase with a C18 column, mobile phase containing acetonitrile - phosphate buffer 0.05 M pH 4.5 (60:40) at a flow rate of 1.0 ml/min using UV detection at 248 nm. To determine BUD, five syrup preparations (brands) obtained from the Jakarta area were analyzed in triplicate. The retention time for ambroxol HCl was 4.62 minutes. In the validation, ambroxol HCl showed good linearity with r = 0.99985 in the 6 to 36 µg/ml. LOD and LOQ for ambroxol HCl were 0.74 µg/ml and 2.25 µg/ml, respectively. It is also fulfilled the accuracy and precision parameters with a % recovery from 99.04% to 100.94% and CV

Original language	English
Pages (from-to)	29-37
Journal	Pharmaceutical Sciences and Research
Volume	10
Issue number	1
DOIs	https://doi.org/10.7454/psr.v10i1.1289
Publication status	Published - 30 Apr 2023

Keywords

ambroxol hydrochloride
Beyond Use Date (BUD)
HPLC
UV/Vis Detector

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http://scholarhub.ui.ac.id/psr/vol10/iss1/2

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@article{9148684f7be34ba0bb9b196f29291cea,

title = "Beyond Use Date (BUD) Determination of Ambroxol Hydrochloride Syrup by High-Performance Liquid Chromatography – UV/VIS Detector",

abstract = "Ambroxol HCl is a mucolytic agent often used to treat respiratory disorders associated with excess mucus secretion. This study aims to determine the beyond-use date (BUD) of ambroxol HCl syrup on the market based on analysis of the decrease in drug content using High-Performance Liquid Chromatography (HPLC) – UV/Vis detector. The HPLC conditions were reversed-phase with a C18 column, mobile phase containing acetonitrile - phosphate buffer 0.05 M pH 4.5 (60:40) at a flow rate of 1.0 ml/min using UV detection at 248 nm. To determine BUD, five syrup preparations (brands) obtained from the Jakarta area were analyzed in triplicate. The retention time for ambroxol HCl was 4.62 minutes. In the validation, ambroxol HCl showed good linearity with r = 0.99985 in the 6 to 36 µg/ml. LOD and LOQ for ambroxol HCl were 0.74 µg/ml and 2.25 µg/ml, respectively. It is also fulfilled the accuracy and precision parameters with a % recovery from 99.04% to 100.94% and CV ",

keywords = "ambroxol hydrochloride, Beyond Use Date (BUD), HPLC, UV/Vis Detector",

author = "Catur Jatmika and Raditya Iswandana and Lestari, {Indah Dewi}",

year = "2023",

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day = "30",

doi = "10.7454/psr.v10i1.1289",

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AU - Jatmika, Catur

AU - Iswandana, Raditya

AU - Lestari, Indah Dewi

PY - 2023/4/30

Y1 - 2023/4/30

N2 - Ambroxol HCl is a mucolytic agent often used to treat respiratory disorders associated with excess mucus secretion. This study aims to determine the beyond-use date (BUD) of ambroxol HCl syrup on the market based on analysis of the decrease in drug content using High-Performance Liquid Chromatography (HPLC) – UV/Vis detector. The HPLC conditions were reversed-phase with a C18 column, mobile phase containing acetonitrile - phosphate buffer 0.05 M pH 4.5 (60:40) at a flow rate of 1.0 ml/min using UV detection at 248 nm. To determine BUD, five syrup preparations (brands) obtained from the Jakarta area were analyzed in triplicate. The retention time for ambroxol HCl was 4.62 minutes. In the validation, ambroxol HCl showed good linearity with r = 0.99985 in the 6 to 36 µg/ml. LOD and LOQ for ambroxol HCl were 0.74 µg/ml and 2.25 µg/ml, respectively. It is also fulfilled the accuracy and precision parameters with a % recovery from 99.04% to 100.94% and CV

AB - Ambroxol HCl is a mucolytic agent often used to treat respiratory disorders associated with excess mucus secretion. This study aims to determine the beyond-use date (BUD) of ambroxol HCl syrup on the market based on analysis of the decrease in drug content using High-Performance Liquid Chromatography (HPLC) – UV/Vis detector. The HPLC conditions were reversed-phase with a C18 column, mobile phase containing acetonitrile - phosphate buffer 0.05 M pH 4.5 (60:40) at a flow rate of 1.0 ml/min using UV detection at 248 nm. To determine BUD, five syrup preparations (brands) obtained from the Jakarta area were analyzed in triplicate. The retention time for ambroxol HCl was 4.62 minutes. In the validation, ambroxol HCl showed good linearity with r = 0.99985 in the 6 to 36 µg/ml. LOD and LOQ for ambroxol HCl were 0.74 µg/ml and 2.25 µg/ml, respectively. It is also fulfilled the accuracy and precision parameters with a % recovery from 99.04% to 100.94% and CV

KW - ambroxol hydrochloride

KW - Beyond Use Date (BUD)

KW - HPLC

KW - UV/Vis Detector

U2 - 10.7454/psr.v10i1.1289

DO - 10.7454/psr.v10i1.1289

M3 - Article

SN - 2477-0612

VL - 10

SP - 29

EP - 37

JO - Pharmaceutical Sciences and Research

JF - Pharmaceutical Sciences and Research

IS - 1

ER -

Beyond Use Date (BUD) Determination of Ambroxol Hydrochloride Syrup by High-Performance Liquid Chromatography – UV/VIS Detector

Abstract

Keywords

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