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WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
Talaviya et al.
World Journal of Pharmacy and Pharmaceutical Sciences
SJIF Impact Factor 2.786
Volume 3, Issue12, 397-409.
Review Article
ISSN 2278 – 4357
ANALYSIS OF ANTIFUNGAL AGENTS BY RP-HPLC: A REVIEW
*1
1
Smita Talaviya and 2Falguni Majmudar
Department of Pharmaceutical Chemistry, K. B. Raval College of Pharmacy, Gandhinagar,
Gujarat, India.
2
Department of Pharmacology, Smt. N.H.L. Municipal Medical College, Ahmedabad,
Gujarat, India.
Article Received on
01 Oct 2014,
ABSTRACT
Revised on 25 Oct 2014,
Accepted on 18 Nov 2014
aspect in drug discovery process. Development of analytical method
Analytical method development and its validation is an important
producing accurate and precise data is necessary to ensure the quality
*Correspondence for Author
and safety of the drug. In today’s scenario, the most common
Smita Talaviya
analytical method employed for estimation of drugs is Reverse Phase
Department of Pharmaceutical
High Pressure Liquid Chromatography (RP-HPLC) because of its high
Chemistry, K. B. Raval College
sensitivity and speed. Many types of analytical methods are available
of Pharmacy, Gandhinagar,
Gujarat, India.
for estimation of antifungal agents including RP-HPLC. This review
article briefly discusses analytical methods available for the estimation
of currently available antifungal agents specifically focusing on RP-HPLC.
KEYWORDS: Antifungal agents, Analytical methods, RP-HPLC, analysis of antifungals.
INTRODUCTION
Fungal infections are caused by microscopic organisms that can invade the epithelial tissue.
The fungal kingdom includes yeasts, molds, rusts and mushrooms. Fungi, like animals, are
heterotrophic, i.e. they obtain nutrients from the environment and not from the endogenous
sources.
Some of these fungi are pathogenic and can produce mild to severe fungal
infections. An antifungal agent is a drug that selectively eliminates fungal pathogens from a
host with minimal toxicity to the host.[1] They can be categorized in to several categories
according to different pharmacophores and different mechanisms. Polyene antifungal drugs
like amphotericin B, nystatin interacts with sterols in the cell membrane to form channels
through which small molecules leak from the inside of the fungal cell to the outside. Azoles
like fluconazole, itraconazole, ketoconazole, clotrimazole, voriconazole, posaconazole etc.
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World Journal of Pharmacy and Pharmaceutical Sciences
inhibit cytochrome P450-dependent enzymes (particularly C14-demethylase) involved in the
biosynthesis of ergosterol, which is required for fungal cell membrane structure and function.
Allylamines like naftifine, terbinafine inhibit ergosterol biosynthesis at the level of squalene
epoxidase. Antimetabolites like 5-Fluorocytosine act as an inhibitor of both DNA and RNA
synthesis via the intracytoplasmic conversion of 5-fluorocytosine to 5-fluorouracil.
Echinocandins like anidulafungin, caspofungin and micafungin are used for systemic fungal
infections in immunocompromised patients, they inhibit the synthesis of glucan in the cell
wall via the enzyme 1,3-β glucan synthase[2,3].
Analytical method Development and validation for newly introduced pharmaceuticals is of
importance, as drug or drug combination may not be official in pharmacopoeia and so
analytical method for quantification is not available. To check and ensure the quality
standards of drug molecules and their formulation various analytical methods are employed.
Most of the drugs in single or multi component dosage forms can be analyzed by HPLC
method because of the associated advantages like speed, greater sensitivity, improved
resolution, specificity, accuracy, precision, reusable columns and ease of automation in this
method.
[4,5,6]
This review article briefly discusses the RP-HPLC methods available for the
estimation of antifungal agents in bulk and in various formulations concentrating mainly on
the mobile phase, stationary phase and detector type.
Table 1 Chromatographic conditions for RP-HPLC methods reported for the estimation
of polyene antibiotics.
Name of
antifungal agent
Nystatin[7]
Nystatin[8]
Nystatin[9]
Nystatin[10]
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Chromatographic
Column
Bulk drug and Symmetry
C18
pharmaceutical
(4.6 x 250 mm, 5
preparation
μm)
Ointment
Inerstil
ODS-3
column (250 x 4.6
mm, 5 μm)
Nystatin,
Inertsil
ODS‐3v
Miconazole,
(250 mm × 4.6
Hydrocortisone
mm, 5 μm)
acetate
and
Neomycin
in
pharmaceutical
preparations
Nystatin
and muBondapark C18
triamcinolone in (150mm × 4.6m, 5
cream
μm)
Sample matrix
Mobile phase
Methanol:water:dimeth
ylformamide (55:30:15
v/v/v)
Methanol:water (75:25
v/v)
Acetonitrile: 25 mM
KH2PO4
buffer,
pH=2.8) (50:50 v/v)
Type of
detector
UV
detection at
305 nm
UV
detection at
305 nm
DAD
acquisition
wavelength
from 200 to
400 nm
Methanol: water (65:35 UV
v/v)
detection at
254 nm
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398
Talaviya et al.
Nystatin[11]
Nystatin[12]
Nystatin[13]
Amphotericin
B[14]
Amphotericin
B[15]
Amphotericin
B[16]
Amphotericin
B[17]
Amphotericin
B[18]
World Journal of Pharmacy and Pharmaceutical Sciences
Liposomal
muBondapak C18 10
mM
sodium
Nystatin
in (150mm × 4.6m, 5 phosphate,
1
mM
plasma and tissue μm)
EDTA, 30% methanol
and 30% acetonitrile
adjusted to pH 6
Miconazole and Phenomenex Luna Methanol:acetonitrile:5
nystatin
C18 column (250 0 mM ammonium
× 4.6 mm, 5 µm)
acetate buffer (pH
adjusted to 6 using
glacial acetic acid)
(60:30:10 v/v/v)
Nystatin
LichrCARTŖ C18 Methanolhydrocortisone,
(250 × 4.6 mm, 5 NaH2PO4/Na2HPO4
and
µm)
gradient elution
oxytetracycline
Bulk and dosage Spheri-5, CYANO 10 mM sodium acetate
form
column (30 × 4.6 buffer:acetonitrile
mm, 5 μm )
(72:28 v/v with pH-4 )
Liposomal
C18
μBondapac Acetonitrile:0.02M
amphotericin B
column (300 × 4.6 ethylenediamine tetramm, 5 μm)
acetic acid disodium
Salt at pH 5 (45:55 v/v)
Amphotericin B, LiChrosorb-RP-8
Acetonitrile:methanol:0
liposomal
column
.010
M
NaH2PO4
amphotericin B,
buffer (41:10:49 v/v)
and amphotericin
B
colloidal
dispersion
in
plasma
Amphotericin B C-18 column
Acetonitrile:20
mM
in human plasma
disodium edetate at pH
5 (45:55 v/v)
Bulk and dosage Luna C18 column Acetonitrile:Tetrahydro
form
(250 x 4.6 mm; furan:o-phosphoric
5μ)
acid, pH=6 adjusted
with TEA (60:30:10
v/v/v)
UV
detection at
305 nm
UV
detection at
230 nm
Diode-array
detector
UV
detection at
408 nm
UV
detection at
407 nm
UV
detection at
405 nm
UV
detection at
407 nm
UV
detection at
287 nm
Table 2 Chromatographic conditions for RP-HPLC methods reported for the estimation
of azoles.
Name
of Sample matrix Chromatographic Mobile phase
antifungal agent
Column
[19]
Fluconazole
Human urine
LichroCART®
Methanol:water
C18 (150 mm x (70:30 v/v)
4.6 mm, 5 μm)
Fluconazole[20]
Fluconazole and Purospher STAR Water:methanol
Related
RP-18 (150 x 4.6 (60:40 v/v)
Compounds in mm, 5 μm)
Capsule
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Vol 3, Issue 12, 2014.
Type
of
detector
UV detection
at 254 nm.
UV detection
at 260 nm
399
Talaviya et al.
Fluconazole[21]
Fluconazole[22]
Fluconazole[23]
Clotrimazole[24]
Clotrimazole[25]
Clotrimazole[26]
Ketoconazole[27]
Ketoconazole[28]
Ketoconazole[29]
Ketoconazole[30]
Ketoconazole[31]
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World Journal of Pharmacy and Pharmaceutical Sciences
Bulk and solid
pharmaceutical
dosage form
Capsules,
uncoated
and
dispersible
Tablets
Biological Skin
Matrices
SunFire C18 (250 Methanol:water
× 4.5 mm, 5 μm)
(70:30 v/v)
UV detection
at 211 nm
C-18 Phenomenix Water:acetonitrile
(150 × 4.6 mm, 5 (65:35 v/v)
μm)
UV detection
at 260 nm
Lichrospher RP 18 Methanol:0.025
column (250 × 4 mol/L phosphate
mm, 5 μm)
buffer pH 7.0
(45:55 v/v)
Lozenges
Gracemart
C18 Methanol:0.1%
(250 × 4.6 mm, TEA in water pH
5μm)
3 adjusted by
Ortho-phosphoric
acid (75:25 v/v)
Beclomethason Reversed
phase Acetate
buffere, Clotrimazole, C18 column (250 acetonitrile with
Chloramphenic x 4.6 mm, 5.0 μm) different gradient
ol, lidocaine in
program
Formulations
Clotrimazole
C-18 Column (150 Methanol:water:di
and
x 4.6 mm, 5 μm)
ethylamine:glacial
ketoconazole in
acetic acid, pH 7
Creams, tablets
(80:20:0.3:0.2
and shampoos
v/v)
Plasma
Inertsil ODS-80A Water:acetonitrile
(150 mm x 4.6 :tetrahydrofuran:a
mm, 5 μm)
mmonium
hydroxide:triethyl
amine(45:50.2:2.5
:0.1:0.1 v/v)
Tablets
and Merck
Diisopropylamine
creams
LiChrospher® 100 :methanol (1:500)
RP-18 (5 μm)
and ammonium
acetate
(1:200)
(8:2)
Commercial
LiChrospher® 100 Triethylamine in
and simulated RP-18 (125 mm x methanol(1:500
emulsion
4 mm, 5 μm)
v/v):ammonium
formulations
acetate in water
(1:200w/v) (75:25
v/v)
Serum (human) MicroPak MCH- Methanol:phosph
10 (30 cm x 4 mm, ate buffer, pH 7.5
10 μm)
(75:25 v/v)
Tablets
and Lichrosorb® RP- Methanol:ammoni
creams
18 (250 mm x 4 um acetate (80:20
mm, 5 μm)
v/v)
UV detection
at 260 nm
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UV detection
at 215 nm
UV detection
at 254 nm
DAD-UV
detection at
224 nm
UV detection
at 206 nm
UV detection
at 225 nm
UV detection
at 225 nm
UV detection
at 231 nm
UV detection
at 225 nm
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Talaviya et al.
World Journal of Pharmacy and Pharmaceutical Sciences
Ketoconazole[32]
Shampoo
Acetonitrile:phos UV detection
phate buffer, pH 4 at 250 nm
(45:55 v/v)
Econazole[33]
Cream
lotion
Interchrom
Nucleosil
C-8
(250 x 4.6 mm, 5
μm)
and RP-18 column
Voriconazole[34]
Bulk and Tablet Inertsil C8 column
Dosage Form
(250 x 4.6 mm,
5μm)
UV
detection at
254 nm
Voriconazole[35]
Voriconazole
for injection
Voriconazole[36]
Voriconazole
for injection
Voriconazole[37]
Intersil ODS-C18
(150 X 4.6 mm,
5μm)
Inertsil ODS-2, C18 (150 × 4.6 mm,
5μm)
Voriconazole
Zorbax
SB-C18
and its related (250mm × 4.6
substances
mm, 5 μm)
Voriconazole[38]
Degradation
Inertsil ODS 3V
impurities and (150 × 4.6 mm, 5
Diastereomers
μm)
in tablets
Voriconazole[39]
Voriconazole
For Injection
Inertsil ODS-2, C18 (150 × 4.6 mm,
5μm)
Voriconazole[40]
Pure
and
Pharmaceutical
Dosage Forms
Stability
indicating
method
Bulk
and
formulat ion
Capsule
RP-C-18 Hypersil
BDS column (250
× 4.6 mm, 5 μm)
Hypersil C18 (250
× 4.6 mm , 5 μm)
Voriconazole[41]
Voriconazole[42]
Itraconazole[43]
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Hypersil C18 (250
× 4.6 mm, 5 μm)
Inertsil C-18, (250
× 4.6 mm, 5 μm)
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Methanol,
aqueous
ammonium
carbonate,
tetrahydrofurane
0.01M
sodium
dihydrogen
orthophosphate,
pH 5:Acetonitrile
(50:50 v/v)
Phosphate buffer:
acetonitrile:Metha
nol
(65:30:5
v/v/v)
OPA:Acetonitrile:
Methanol
(65:30:5 v/v/v)
Ammonium
phosphate dibasic
buffer, pH=6 by
orthophosphoric
acid:acetonitrile
(52:48 v/v)
0.05 M potassium
dihydrogen
phosphate,
pH
2.5:mixture
of
acetonitrile and
methanol (90:10
v/v)
Ortho phosphoric
acid:acetonitrile:
methanol (65:30:5
v/v/v)
Water:acetonitrile
:methanol
(50:25:25 v/v/v)
Acetonitrile:water
(40:60 v/v)
Water:acetonitr
ile (35:65 v/v)
Tetrabutyl
ammonium
hydrogen sulphate
buffer:Acetonitril
UV detection
UV detection
at 257 nm
UV detection
at 257nm
UV detection
at 250 nm
UV detection
at 256 nm
UV detection
at 257nm
UV detection
at 256 nm.
Photodiode
array
detector
UV detection
at 256 nm
UV detection
at 225nm
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World Journal of Pharmacy and Pharmaceutical Sciences
[44]
Itraconazole
Zorbax
Eclipse
and
its XDB-C18 (4.6 ×
impurities
150 mm, 5 μm)
Itraconazole[45]
Capsule dosage ThermoHypersil
form
BDS C18 (150mm
x 4.6 mm, 5μm)
Itraconazole[46]
Itraconazole
and
hydroxyl
itraconazole in
plasma
Capsule
Itraconazole
Itraconazole[47]
Itraconazole[48]
Posaconazole[49]
Posaconazole[50]
Posaconazole[51]
Bifonazole[52]
Sertaconazol[53]
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Shimadzu
C-18
column (3.9 mm ×
150 mm, 5μm)
e (40:60 v/v)
Acetonitrile:water
, pH 2.5 adjusted
with o-phosphoric
acid (50:50 V/V)
Tetra
Butyl
Ammonium
Hydrogen
Sulphate:acetonitr
ile (65:35 v/v)
Methanol:water
(75:25 v/v)
Dionex C-18 (250 Potassium
x 4.6 mm, 5 μm)
dihydrogen
phosphate
buffer:Methanol
(60:40 v/v)
Itraconazole
Acclaim
RSLC Ammonium
and
Related 120, C18 (2.1 × acetate
Substances
100 mm, 2.2 μm)
buffer:CH3CN
gradient technique
Human serum
Sunfire C18 (4.6 x Acetonitrile:water
150 mm, 5 μm)
(60:40 v/v)
Posaconazole
Sunfire C-18 (250 Acetonitrile:water
and its related mm x 4.6 mm, (90:10 v/v)
substances
5μm)
Bulk Assay
C8 column
Methanol:water
(75:25 v/v)
Cream
Hypersil ODS.
0.08
mol/L
triethylamine
phosphate, pH 7
:acetonitrile:meth
anol
(20:10:70
v/v/v)
Cream
Spherisorb
CN Acetonitrile:0.01
column
(10 M
sodium
microns)
phosphate (37:63
v/v)
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UV detection
at 256 nm
UV detection
at 225nm
Fluorometric
detection at
250
and
380nm
UV detection
at 306 nm
UV detection
at 225 nm
UV detection
at 262 nm
UV detection
at 210 nm
UV detection
at 260 nm
UV detection
at 254 nm.
UV detection
at 260 nm
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World Journal of Pharmacy and Pharmaceutical Sciences
Table 3 Chromatographic conditions for RP-HPLC methods reported for the estimation
of allylamines.
Name
of Sample matrix
antifungal agent
Terbinafine[54]
Terbinafine
Hydrochloride
in
Semi Solids Dosage
Form
Type
of
detector
Methanol:acetonitrile PDA
(60:40 v/v) with detection at
(0.15% triethylamine 224 nm
and
0.15%
phosphoric acid )
PH=7.68
Terbinafine
RP C18 (250 mm Methanol:water
UV
Hydrochloride
in × 4.6mm 5μ)
(80:20 v/v)
detection at
pharmaceutical solid
282 nm
dosage form
Pharmaceutical
Vertical® RP-C18 Methanol:water (95:5 UV
hydroalcoholic
(250 mm × 4.6 v/v)
detection at
solutions and tablets
mm, 5 μm)
254 nm
Terbinafine
C18 Enable (250 × Methanol:Water
UV
Hydrochloride
and 4.6 mm, 5 μm)
(95:5 v/v)
detection at
Mometasone furoate
248 nm
in combined dosage
form
Terbinafine
Neosphere
C18 Methanol:0.5%
UV
Hydrochloride
in (250 x 4.6 mm, triethanolamine (v/v) detection at
Bulk and in Tablet 5μm)
250 nm
dosage form
Butenafine
Inertsil C18 (250 × Methanol and water UV
Hydrochloride
and 4.6 mm, 5μm)
in gradient technique detection at
Betamethasone
254 nm
Dipropionate in a
Cream Formulation
Terbinafine[55]
Terbinafine[56]
Terbinafine[57]
Terbinafine[58]
Butenafine[59]
Chromatographic
Column
Intersil
L1ODS
(4.6 mm × 15cm 5
μg)
Mobile phase used
Table 4 Chromatographic conditions for RP-HPLC methods reported for the estimation
of echinocandins.
Name
of Sample matrix
antifungal agent
Anidulafungin[60]
Human Plasma and
Saline
Anidulafungin[61]
Micafungin[62]
Chromatographic
Column
Zorbax
SB-C8
column (4.6 × 250
mm, 5 μm)
Bulk sample and YMC ODS Pack AQ
parenteral dosage C18 (150 x 4.6 mm, 3
form
μm)
Micafungin Sodium Agilent Zorbax SB
in drug substances
(250 × 4.6 mm, 5 μm)
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Vol 3, Issue 12, 2014.
Mobile phase used
0.005 M ammonium
phosphate
buffer:
methanol (55:45 v/v)
Acetonitrile:water:0.1
% v/v trifluoroacetic
acid (48:52:1 v/v/v)
Buffer
consisting
sodium
dihydrogen
phosphate and sodium
perchlorate
PH
2.9:acetonitrile (62:38
v/v)
Type
of
detector
UV
detection
at 310 nm.
UV
detection
at 300nm.
DAD
at
210 nm
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World Journal of Pharmacy and Pharmaceutical Sciences
CONCLUSION
Presented review covers the analytical methods for the determination of antifungal agents in
various pharmaceutical and biological samples alone or in combination with other drugs with
help of RP-HPLC. For quantitative estimation of antifungal agents, RP-HPLC method is the
most common among others. All the reported methods are sensitive, precise and accurate;
consisting mainly RP C18 column as stationary phase and variety of polar solvents (like
methanol, water, acetonitrile, buffers) in different ratios as mobile phase. For development of
analytical methods, for newly developed or for upcoming novel antifungal agents, this can be
taken for consideration.
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