HPLC methods on drug analysis

598 Pages·1992·31.705 MB·English

by  Dr. Mantu Kumar Ghosh (auth.)

Mantu K. Ghosh
HPLC Methods
on Drug Analysis
Springer-Verlag
Berlin Heidelberg New York
London Paris Tokyo
Hong Kong Barcelona Budapest
Dr. Mantu Kumar Ghosh
4420 Coesfeld, Germany
Library of Congress Cataloging in Publication Data
Ghosh, Mantu K. (Mantu Kumar), 1942-
HPLC methods on drug analysis / Mantu K. Ghosh.
Includes index.
ISBN-13: 978-3-540-53824-0 e-ISBN-13: 978-3-642-76506-3
DOl: 10.1007/978-3-642-76506-3
I. High performance liquid chromatography - Laboratory manuals.
2. Drugs - Analysis - Laboratory manuals. I. Title.
[DNLM: I. Chromatography, High Pressure Liquid - methods - laboratory manuals.
2. Drugs - analysis laboratory manuals. QV 25 G427h]
RSI89.5.H54G47 1992
615'. 1901--dc20
DNLM/DLC
This work is subject to copyright. All rights are reserved, whether the whole or part of the
material is concerned, specifically the rights of translation, reprinting, re-use of illustra
tions, recitation, broadcasting, reproduction on microfilms or in other ways, and storage
in data banks. Duplication of this publication or parts thereof is only permitted under
the provisions of the German Copyright Law of September 9, 1965, in its current version
and a copyright fee must always be paid. Violations fall under the prosecution act of the
German Copyright Law. Neither the author nor the publisher is responsible for the
reproducibility of the described methods.
© Springer-Verlag Berlin Heidelberg 1992
The use of registered names, trademarks, etc. in this publication does not imply, even in
the absence of a specific statement, that such names are exempt from the relevant
protective laws and regulations and thereof free for general use.
Typesetting: Macmillan India Ltd. Bangalore 25.
52/3020-54321O-Printed on acid-free paper.
Dedicated to the memory of my parents
Contents
1 Preface............. IX
2 Abbreviations......... XI
3 List of the Described Drugs xiii
4 Explanatory Notes. . . . . . 1
5 Drug Monographs. . . . . . 5
6 Conversion of Imperial and SI Unit Equivalents of other Units 570
7 Atomic Mass of the Elements . 573
8 Miscibility of Solvents. . . . . . . . . . . . . . . . . . . . . . . 576
9 Characteristics of the Solvents. . . . . . . . . . . . . . . . . . 578
10 Characteristics of the Common HPLC Separation Systems
(columns) . . . . . . . . . . 580
11 Sorbent Selection Guides. . . . . . . . . . . . . . . . . . . . . 584
Preface
The dramatic development of chromatographic techniques, specially high per
formance or high pressure liquid chromatography (HPLC) has made possible the
easy analysis of organic compounds, including drugs and drug components, for
last two decades.
This rapid increase and improvement of analytical methodology with HPLC
has enabled researchers and scientists to cope with other scientific and instru
mental developments in their fields of work.
Thousands of impressive and original scientific publications, text books and
monographs describe the techniques for drug analysis with high performance
liquid chromatography. However, no concise presentation of the general proper
ties of the drugs and their HPLC methodology exists together in the market. This
work contains the general properties necessary for the analysis of 232 drugs as
well as the HPLC methods for many other drugs and drug components. It is
hoped that it will fill a gap and provide a precise survey of the HPLC methods for
drug analysis. It is intended as an immediate guide in the laboratory and will be
of help to the scientists, researchers and technicians in the field of analysis.
This book describes approx. 1300 HPLC methods, in a precise form, for the
analysis of some hundreds of drugs and drug components from raw materials,
pharmaceuticals and biological samples under 232 headings. Emphasis is laid on
the important points of the general properties of the described drugs, extraction,
apparatus, column, eluent, temperature, injection size, detection, retention times
and references whereever possible. The tabular presentation is very easy to
understand with minimum knowledge of chemistry as well as of HPLC for the
quantitative analysis of drugs.The preservatives used in drugs are considered,
since they are also a part of the pharmaceutical formulations in most cases, and
some autocoids used for diagnostic purposes or treatment are also described
here.
I must express my love for and gratitude to my wife, Manikuntala Ghosh, B.Sc.
for her direct help in the preparation of the manuscript. I highly appreciate and
thank Mrs. K. Rausse, Muenster, for her patience in typing the manuscript. I also
take this opportunity to thank many of my friends for their inspiration for this
work to become a reality.
Coesfeld, Germany, M.K. Ghosh
Abbreviations
A ampere ID inner diameter
Afs ampere full scale In inch
r1 alpha insol insoluble
appr. approximately IV international unit
aq aqueous k' (column) capacity factor or
AU absorbance units capacity ratio
AUFS absorbance units full scale kg kilogram
~ beta kPa kilopascal
BP British Pharmacopoeia I liter
°C degree Celsius, centigrade Ib,lbs pound, pounds
CAS chemical abstract service LC liquid chromatography
Ci curie LDC Laboratory Data Control
cm centimeter L levo (rotatory)
CNS central nervous system m milli ( = 10 -3); also, meter
D dextro (rotatory) m meta-
S delta M molar (mol/I) or model
EC electrochemical (apparatus)
Ed editor or edited by max maximum
Edn edition mg milligram
EDTA ethylenediaminetetraacetic acid min minute
em emission ml milliliter
et al. et alii, 'and others' for more mm millimeter
than three co-authors mM millimole
eV electron volt mol mole
ex excitation MPa mega pascal
OF degree Fahrenheit mV millivolt
FID flame ionization detector ~ micro ( = 10 -6); also, ionic
fg femtogram ( = 10 -1 5 g) strength
fmol femtomol microgram ( = 10-6 g)
~g
FS full scale ~I microliter ( = 10-61)
fsd full scale deflection micrometer
~m
g gram (10-6 m = 10-4 cm)
y gamma n nano ( = 10-9);
GC glassy carbon (electrode) normal in organic names, e.g.,
h hour n-butylamine
HP Hewlett-Packard N normal (solution); nitrogen, e.g.,
HPLC high-performance liquid N-Acety1cysteine
chromatography; also, NF National Formulary
high-pressure liquid ng nanogram ( = 10 -9 g)
chromatography nm nanometer ( = 10-9 m)
i (or ~) ionic strength nM nanomol
xii Abbreviations
No number RI refractive index
NP normal phase RP reversed-phase
0- ortho- RT retention times
0 attachment to oxygen S stereo (isomer)
p- para- s second
Pa pascal sol solution or soluble
pg picogram ( = 10 -12 g) SP Spectra-Physics
pH hydrogen ion exponent "- lambda (wavelength, nm)
PLRP polymeric reversed-phase tert.- tertiary, e.g., tert.-butanol
pmol picomol USP United States Pharmacopeia
ppb parts per billion UV ultraviolet
ppm parts per million V volt
PRP polymeric reversed-phase VIS visible
psi pounds per square inch vs versus, against
R racemic (isomer) v/v volume per volume
RCM radial compression module w/v weight per volume
RCSS radial compression separation w/w weight per weight
system > greater than; faster than
RE reference electrode < less than; slower than
ref. reference degree(s) Celsius, centigrade
List of the Described Drugs
1 Acetylcysteine, 5 38 Chlorothiazide, 91
2 Acetylsalicylic Acid, 6 39 Chlorpheniramine, 93
3 Acyclovir, 9 40 Chlorpromazine, 96
4 Allopurinol, 10 41 Chlorpropamide, 100
5 Amiodarone, 13 42 Chlorprothixene, 101
6 Amitriptyline, 15 43 Chlortetracycline, 105
7 Amobarbital, 19 44 Chlorthalidone, 108
8 Amoxicillin, 22 45 Choline, 110
9 Amphetamine, 25 46 Cimetidine, 112
10 Amphotericin B, 27 47 Clavulanic Acid, 115
11 Ampicillin, 30 48 Clindamycin, 117
12 Ascorbic Acid, 32 49 Clonalepam, 119
13 Atropine, 35 50 Clonidine, 122
51 Cloxacillin, 123
52 Cocaine, 126
14 Bacampicillin, 37 53 Codeine, 129
15 Bacitracin, 39 54 Colistin, 131
16 Beclomethasone, 42 55 Cortisone, 133
17 Benzalkonium Chloride, 43 56 Cyanocobalamin, 136
18 Benzyl Alcohol, 44 57 Cyclosporin A, 139
19 Benzylpenicillin, 46
20 Betamethasone, 49
21 Bleomycin Sulfate, 51 58 Daunorubicin, 142
22 Bupivacaine Hydrochloride, 54 59 Deoxycortone, 145
60 Dexamethasone, 147
61 Dextrose, 150
23 Caffeine, 56 62 Diazepam, 152
24 Carbamazepine, 58 63 Dicloxacillin, 155
25 Carbenicillin, 61 64 Dicoumarol, 157
26 Cefamandole, 64 65 Digitoxin, 158
27 Cefazolin Sodium, 66 66 Digoxin, 161
28 Cefixime, 68 67 Diltiazem Hydrochloride, 164
29 Cefotaxime, 69 68 Dimetridazole, 167
30 Ceftriaxone, 72 69 Dopa (Levodopa), 169
31 Cephalexin, 73 70 Dopamine, 171
32 Cephalothin, 77 71 Doxorubicin (Adriamycin), 174
33 Cephradine, 79 72 Doxycycline, 178
34 Chlorambucil, 81
35 Chloramphenicol, 83
36 Clordiazepoxide, 86 73 Ephedrine, 180
37 Chloroquinine, 88 74 Epinephrine, 184
XIV List of the Described Drugs
75 Ergometrine, 188 114 Mebendazole, 279
76 Ergotamine, 190 115 Meclizine, 281
77 Erythromycin, 192 116 Medazepam, 282
78 Estradiol, 195 117 Medroxyprogesterone Acetate, 284
118 Melphalan, 286
119 Mepyramine, 289
79 Fenbendazole, 199 120 Methadone, 290
80 Fentanyl, 201 121 Methylparaben, 293
81 Flumequine, 202 122 Metronidazole, 295
82 5-FluorouraciI, 203 123 Mezlocillin, 297
83 Flurbiprofen, 206 124 Miconazole, 299
84 Folic Acid, 207 125 Minoxidil, 301
85 Fructose, 209 126 Morphine, 302
86 Furazolidone, 211
87 Furosemide, 213
127 NadoloI, 305
128 Nalidixic Acid, 308
88 Gentamicin, 216 129 Naloxone, 310
89 Globulins, 219 130 Nandrolone, 312
90 Griseofulvin, 221 131 Neomycin, 314
132 Nicotinamide, 317
133 Nicotine, 319
91 Haloperidol, 223 134 Nifedipine, 321
92 Heroin, 226 135 Nitrofurantoin, 324
93 Hexobarbital, 229 136 Nitrofurazone, 325
94 Histamine, 231 137 Nitroglycerin, 327
95 Hydrocortisone, 232 138 Norepinephrine, 330
139 Novobiocin, 332
140 Nystatin, 335
96 Ibuprofen, 236
97 Idoxuridine, 239
98 Imipramine, 240 141 Oleandomycin, 336
99 Indomethacin, 243 142 Oxazepam, 338
100 Insulin, 245 143 Oxytetracycline Dihydrate, 341
10 1 Isoniazid, 248 144 Oxytocin, 345
102 Isoprenaline, 251
103 I vermectin, 252
145 Pantothenic Acid, 347
146 Paracetamol, 349
104 Kanamycin, 255 147 Penicillin V, 354
105 Ketamine, 258 148 Pentobarbital, 356
106 Ketoconazole, 259 149 Phenacetin, 358
107 Ketoprofen, 261 150 Phenazone, 361
151 Pheniramine, 363
152 Phenobarbital, 365
108 Labetalol, 265 153 Phenol, 368
109 Lactose, 267 154 Phenprocoumon, 370
110 Levamisole, 270 155 Phenylbutazone, 372
111 Lidocaine, 271 156 Phenytoin, 374
112 Lorazepam, 274 157 Physostigmine, 377
113 Lysergide (LSD), 277 158 Pilocarpine, 379