Joko Sulistiyo Journal of Drug Delivery & Therapeutics. 2023; 13(6):141-144
ISSN: 2250-1177 [141] CODEN (USA): JDDTAO
Available online on 15.06.2023 at http://jddtonline.info
Journal of Drug Delivery and Therapeutics
Open Access to Pharmaceutical and Medical Research
Copyright © 2023 The Author(s): This is an open-access article distributed under the terms of the CC BY-NC 4.0 which
permits unrestricted use, distribution, and reproduction in any medium for non-commercial use provided the original
author and source are credited
Open Access Full Text Article Research Article
Assay of Diphenhydramine HCl in Syrup by High Performance Liquid
Chromatography
Joko Sulistiyo
Health Polytechnic of Jakarta II, Jakarta, Indonesia
Article Info:
_____________________________________________
Article History:
Received 23 April 2023
Reviewed 14 May 2023
Accepted 27 May 2023
Published 15 June 2023
_____________________________________________
Cite this article as:
Sulistiyo J, Assay of Diphenhydramine HCl in
Syrup by High Performance Liquid
Chromatography, Journal of Drug Delivery and
Therapeutics. 2023; 13(6):141-144
DOI: http://dx.doi.org/10.22270/jddt.v13i6.5885
_____________________________________________
*Address for Correspondence:
Joko Sulistiyo, Health Polytechnic of Jakarta II,
Jakarta, Indonesia
Abstract
_____________________________________________________________________________________________________________________
Cough is a natural response from the respiratory tract by increasing the clearance of secretions and
particles from mucus, irritants, foreign particles, and microbes, so that it can act as a body defense.
One way that can be done to relieve cough symptoms is to use symptomatic drugs. Diphenhydramine
HCl is an antihistamine that belongs to the first generation H1 receptor antagonist (H1 blocker) group
which has sedative and anti-allergic properties. Diphenhydramine HCl is used to treat sneeze, runny
nose, watery eyes, itches, skin rashes, and other cold symptoms or other allergies. Diphenhydramine
HCl is also used to treat motion sickness and to induce sleep. The purpose of this study was to
determine the contents of diphenhydramine HCl syrup sold in the market. This test uses the High
Performance Liquid Chromatography (HPLC) method with acetonitrile as a mobile phase; water;
triethylamine (50;50;0.5). The results obtained the average content of Diphenhydramine HCl 102.5%.
So it can be concluded that the cough medicine sample meets the requirements because the contents
are not less than 90% and not more than 110% based on the Indonesian Pharmacopoeia Edition VI
2020.
Keywords: Cough, Diphenhydramine HCl, High Performance Liquid Chromatography (HPLC)
INTRODUCTION
Coughing is a natural response from the respiratory tract by
increasing the cleaning of secretions and particles from mucus,
irritants, foreign particles, and microbes, so that they can act
as the body's defense. There are two types of cough, namely
productive cough (phlegm) and non-productive cough (dry). A
productive cough is a cough that produces phlegm or mucus
(sputum) so it is known as a cough with phlegm. Non-
productive cough is a cough without phlegm, this cough is
often triggered by food particles, irritants, cigarette smoke,
and changes in temperature.
1–4
One way that can be done to relieve cough symptoms is to use
symptomatic drugs. There are many types of drugs used in
cough management, depending on the type of cough that has
the most effect on cough symptoms. Based on their
mechanism of action, cough medicines can be grouped into 3
major groups, namely: expectorants, which have two
mechanisms of action. First, it reacts directly by stimulating
mucus secretion so that mucus is thinner and easier to
remove. Second, by reacting indirectly by irritating the
gastrointestinal tract which affects the respiratory system
thereby increasing mucus secretion; mucolytic, as the name
implies, mucolytic is a cough medicine with phlegm that works
by destroying phlegm formations so that the phlegm becomes
watery; and antitussive, are drugs that work to reduce the
sensitivity of the cough center in the brain to incoming
stimuli.
5–7
Diphenhydramine HCl is an antihistamine which belongs to
the first generation of H1 receptor antagonists (H1 blockers)
which has sedative and antiallergic properties.
Diphenhydramine HCl is used to treat sneezing, runny nose,
watery eyes, itching, skin rashes, and other cold or allergy
symptoms. Diphenhydramine HCl is also used to treat motion
sickness and to induce sleep. Diphenhydramine HCl has
physical properties in the form of a white crystalline powder,
odorless and has a bitter taste. Diphenhydramine HCl is easily
soluble in water, in ethanol, and in chloroform; slightly soluble
in acetone; very difficult to dissolve in benzene and in ether.
8,9
Because there are already many companies that produce the
drug Diphenhydramine HCl, it is necessary to test the drug
preparation with several existing parameters and according to
the requirements. A quality drug is a drug that is guaranteed
that the drug has the potential or power to be used for its
purpose, meets purity requirements, has clear and correct
identity and labeling, is packaged in appropriate packaging
and is protected from damage and contamination, looks good,
and is free from contamination. from defects or damage.
10
Drugs that are marketed in dosage form in the form of syrup
must go through several testing processes. One of them is the
determination of the levels of active substance preparations.
The author wants to know whether the drug
Diphenhydramine HCl in the form of syrup that is circulating
in the market is of good quality to be marketed to the public or
not.
11,12