1. No category

ABBREVIATIONS
% = percentage
TGA= Thermogravimetric Analysis
µg/ml = microgram/milliliter
IR= Infrared Spectroscopy
µm = micrometer(s)
NIR/NIRS= Near infrared Spectroscopy
BP = British pharmacopoeia
CCD= charge-coupled device
CAS = Chemical Abstracts Service
KSM= Key starting material
ACN= Acetonitrile
M = Molarity
CNS = Central Nervous System
mM = Millimolar
OPA= Orthophosphoric Acid
Min = minute
TEA= Triethylamine
ml/min = milliliter/minute
FDA = Food and Drug
NF = National Formulary
Administration
RC= Related Compound
KH2PO4= Potassium dihydrogen
NMR = Nuclear Magnetic Resonance
Orthophosphate
MS= Mass spectroscopy
GERD = Gastro Esophageal Reflux
GC= Gas Chromatography
Disease
KBr= Potassium Bromide
Gms/mol = grams/mole
PPM/ppm= Parts per Million
HCl = Hydrochloride
pH = Power of Hydrogen
i.d = internal diameter
PO4 = phosphate
JP = Japanese Pharmacopoeia
q.s = quantity sufficient
LC = Liquid Chromatography
r = Correlation coefficient
LOQ = Limit of Quantitation
RP = Reverse Phase
QL = Quantitation limit
S/N =signal-to-noise ratio
°C = degree Celsius /Centigrade
v/v = volume in volume
AR =Analytical (Grade) Reagent
mcg =microgram
AUC = Area Under Curve
mg = milligram
Gm = gram
ml/mL = milliliter
mm = millimeter
IP = Indian Pharmacopoeia
LOD = Limit of Detection
DL = Detection limit
DSC= Differential Scanning
N = Theoretocal plates
Nm = nano meter
ODS =OctaDecyl Silane
PDA= Photodiode arra Detector
Calorimetry
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PF = Pharmacopeial Forum
Ph.Eur = European Pharmacopoeia
PPIs = Proton-pump Inhibitors
PUD =Peptic Ulcer Disease
r2 = Linear regression
RSD = Relative Standard Deviation
SD = Standard Deviation
UV = Ultra violet
µg = microgram(s)
ρ = rho
OQ = Operational Qualification
MQ = Maintenance Qualification
HPLC = High Performance /Pressure
Liquid Chromatography
ICH = International Conference on
Harmonization
USP = United States of
Pharmacopoeia
IQ = Installation Qualification
PQ = Performance Qualification
S = Slope
LED= Light emitting diode
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CONTENTS
No
Page
Chapter 1- General Introduction
Introduction
1
Instrumental Analysis
1
Pharmaceutical analysis
2
Combination drug products
3
Drug –Drug chemical interactions
3
High Performance Liquid Chromatography (HPLC)
7
Ultra Performance Liquid chromatography (UPLC)
17
Polymorphism in pharmaceutical solids
19
Method development by HPLC
22
Analytical method validation
25
References
31
Chapter 2
Method Development for Related substances of Atorvastatin &
Clopidogrel in combination by UPLC
Introduction
33
Structure confirmation of Atorvastatin Calcium
37
Impurities of Atorvastatin
41
Structure confirmation of Clopidogrel Bisulphate
45
Impurities of Clopidogrel Bisulphate
49
Method development by UPLC
51
Method validation
79
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Conclusion
99
References
100
CHAPTER 3
Method Development and validation for related substances of
Bisoprolol & Hydrochlorothiazide in combination by UPLC
Introduction
102
Structure confirmation of Bisoprolol Fumarate
106
Impurities of Bisoprolol Fumarate
109
Structure confirmation of Hydrochlorothiazide
111
Impurities of Hydrochlorothiazide
114
Method development by UPLC
115
Method validation
138
Conclusion
154
References
155
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CHAPTER 4
Method Development and validation for related substances of
Omeprazole by UPLC
Introduction
157
Structure confirmation of Omeprazole
159
Impurities of Omeprazole
166
Method development by UPLC
169
Method validation
187
Conclusion
199
References
200
CHAPTER 5
Method Development and validation for related substances of
Montelukast & Cetirizine in combination by HPLC
Introduction
201
Structure confirmation of Montelukast
205
Impurities of Montelukast
209
Structure confirmation of Cetirizine Dihydrochloride
212
Impurities of Cetirizine Dihydrochloride
216
Method development by HPLC
219
Method validation
242
Conclusion
272
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References
273
CHAPTER 6
Method Development and validation for Polymorphic purity
determination of Sertraline Hydrochloride by NIR
Near-infrared spectroscopy
274
Sertraline Hydrochloride introduction
283
Sertraline Polymorphic purity Method by NIR
280
Conformity Index method
285
Quantitative model
286
Conclusion
293
References
294
Page 11 of 305