Bioanalytical Methods

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LIST OF VALIDATED METHODS
S.No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Name of the molecule Aceclofenac Adefovir Alendronet Sodium Alendronet Sodium Alfuzosine Alprazolam Amoxycillin + Clavulanate Amoxycillin Amlodipine+Atenolol Aripiprazole Atenolol Atorvastatin Atorvastatin+Ortho+Para OH Atorvastatin Amlodipine Amlodipine Amiodarone +Desethyl Amiodarone Anastrazole Aspirin+Salicylic acid Atomoxetine Atazanavir Abacavir Abacavir+Lamividine Azithromycin Instrument HPLC/VWD LC-MS/MS HPLC/FLD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS Biological Matrix Plasma Plasma Urine Urine Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Sensitivity (LOQ) 50 ng/ml 1 ng/ml 5 ng/ml 5 ng/ml 0.156 ng/ml 0.2 ng/ml 100 ng/ml + 10 ng/ml 50.6ng/mL 50.0pg/ml+5.0ng/ml 0.2 ng/ml 5.0 ng/ml 0.1 ng/ml 0.5+0.5+0.05 ng/ml 100pg/ml 50 pg/ml 3.0 ng/ml+1.0 ng/ml 0.1 ng/ml 2ng/ml+20ng/ml 0.80 ng/ml 5.0 ng/ml 40ng/mL 40ng/mL+20ng/Ml 20ng/ml

LIST OF VALIDATED METHODS
S.No. 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 Compound (Analyte & Metabolite) Balsalazide+5-Amino Salycilic acid Benazepril + Benazeprilate Bupropion + Hydroxy Bupropion Bisoprolol Bisoprolol Bicalutamide Carvedilol + Hydroxy Carvedilol Captopril Candesartan Candesartan+HCTZ Cefdinir Cefixime Cefuroxime axetile Cefprozil Clarithromycin Clarithromycin+OH Clarithromycin Clopidogrel+Carboxylic Acid Clopidogrel Clopidogrel+Carboxylic Acid Clopidogrel Clindamycin Citalopram Cilastazole Method LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Sensitivity (LOQ) 5.0ng/ml+4.0ng/ml 5.0 ng/ml + 5.0 ng/ml 0.5 ng/ml + 2.0 ng/ml 0.2 ng/ml 50 pg/ml 10 ng/ml 0.5 ng/ml + 0.2 ng/ml 5 ng/ml 2 ng/ml 2ng/ml+2ng/ml 40.17 ng/ml 100.0 ng/ml 20ng/ml 100ng/ml 64.87 ng/ml 50ng/ml+5ng/ml 0.1ng/ml+30.0ng/ml 0.02ng/ml+0.5 ug/ml 50ng/ml 0.1ng/ml 10 ng/ml

LIST OF VALIDATED METHODS
S.No Compound (Analyte & Metabolite) Method Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Sensitivity (LOQ)

45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65

Ciprofibrate Ciprofloxacin Cetrizine Codeine Cyclobenazeprine Didanosine Divalproex Sodium Diclofenac Desogestrol(3-Keto desogestrol) Dyperidamole Doxazosine Doxicycline Duloxetine Dutasteride Donepezil Drosperinone Efavirinz Escitalopram Oxalate Emtricitabine Emtricitabine+Efavirinz Emtricitabine+Tenofavir

HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS

50 ng/ml 10ng/ml 2.0ng/ml 1.0 ng/ml 0.5 ng/ml 2.0 ng/ml 0.5 µg/ml 10ng/ml 40 pg/ml 5.0 ng/ml 0.10 ng/ml 10ng/ml 0.1ng/ml 50 pg/ml 0.1ng/ml 0.5ng/ml 20ng/ml 0.2 ng/ml 5ng/ml 5ng/ml+20ng/ml 5.0ng/ml+4.0ng/ml

LIST OF VALIDATED METHODS
S.No Compound (Analyte & Metabolite) Method Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Sensitivity (LOQ)

66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87

Entacapine Erdosteine Esomeprazole Estrdiol-17 beta Estrone sulfate+Equilin sulfate Free Estrone+Free Equilin Ethinyl Estradiol Exemistane Famciclovir Felodipine Fexofenadine Fenofibric acid Felbamate Fosinopril + Fosinoprilate + Hydrochlorothiazide Fosinoprilate Flecainide Fluvoxamine Flucloxacillin Fluoxetine Fluoxetine+NorFluoxetine Fluconozole Furosemide

HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS

20 ng/ml 5.0 ng/ml 2.0ng/ml 2.5 pg/ml 50pg/ml+50pg/ml 5pg/ml+5pg/ml 5.0pg/ml 0.2ng/ml 50ng/Ml 0.1 ng/ml 2ng/ml 50 ng/ml 1 ug/ml 0.31 ng/ml + 5.34 ng/ml + 1.01 ng/ml 0.5 ng/ml 0.8 ng/ml 2.0 ng/ml 100ng/ml 0.1 ng/ml 0.2ng/ml+0.2ng/ml 10 ng/ml 5ng/ml

LIST OF VALIDATED METHODS
S.No 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 Compound (Analyte & Metabolite) Finasteride Gabapentine Galantamine Gestodine Gemfibrozil Glipizide Glimipride Glyburide Greseofulvin Guifenesine+Dextromethorphan Guifenesine+Pseudoephedrine Hydrochlorothiazide Ibuprofen Isosorbide mono nitrate Isosorbide mono nitrate Irbesartan Irbesartan Irbesartan+Hydrochlorothiazide Itraconazole+Hydroxy Itraconazole Ibandronate Indapamide Method LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Whole Blood Sensitivity (LOQ) 0.2ng/ml 10 ng/ml 0.2 ng/ml 50 pg/ml 0.5 µg/ml 2.54 ng/ml 1.0 ng/ml 0.5ng/ml 10ng/ml 20ng/ml+0.1ng/ml 20ng/ml+5ng/ml 2ng/ml 300 ng/ml 4 ng/ml 10 40.0 ng/ml 5.0ng/ml 10ng/ml+2ng/ml 0.5 ng/ml+2 ng/ml 3.0ng/ml 0.5ng/ml

LIST OF VALIDATED METHODS
S.No 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 Compound (Analyte & Metabolite) Method LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS ICP-OES LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Sensitivity (LOQ) 20ng/ml 0.1ng/ml 5.03 ng/ml 1.0 ng/ml 15.62 ng/ml 5 ng/ml+2 ng/ml 50ng/ml 150 ng/ml 0.5 ng/ml 0.5 ng/ml 50 ppb 10.0 ng/ml +18.1 ng/ml + 2.0 ng/ml 10.0 ng/ml + 20.1 ng/ml 0.05 ng/ml + 0.07 ng/ml 20ng/ml+3.0ng/ml 0.1ng/ml+0.05 ng/ml 10ng/ml+10ng/ml 20.0ng/ml 0.1ng/ml 0.3 ng/ml

Indomethasin Isradipine Lamotrigine Lansaprazole Lansaprazole Levidopa+Carbidopa Levofloxacin Levetiracetam Letrozole Lisinopril Lithium Losartan + Losartan Carboxylic acid + Hydrochlorothiazide Losartan Potassium + Losartan Carboxylic acid Lovastatin + Hydroxy Lovastatin Lopinavir+Ritonavir Loratadine+Desloratadine Lamivudine+Nevirapine Lamivudine Levonorgestrol Levonorgestrol

LIST OF VALIDATED METHODS
S.No Compound (Analyte & Metabolite) Method Biological Matrix Sensitivity (LOQ)

129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148

Levomepramazine+NdesMethyl Levomepramazine Linezolide Medroxy Projesterone acetate Meloxicam Metformin Metoprolol Succinate Memantine Mesalamine(5-ASA) Methyl phenidate Metaxalone Minocycline Mirtazapine Montelukast Modafinil Mosapride Moxifloxacin Mycophenolic acid Nevirapine Niacin+Niotinuric acid Norgestimate

LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS

Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma

0.05ng/ml+0.05ng/ml 100ng/ml 0.05ng/ml 5 ng/ml 10 ng/ml 2.00 ng/ml 0.2 ng/ml 4.0 ng/ml 0.1 10 ng/ml 10ng/ml 0.2 ng/ml 2.0 ng/ml 20 ng/ml 1 ng/ml 50 ng/ml 30ng/ml 50ng/ml 50+10ng/ml 50pg/ml

LIST OF VALIDATED METHODS
S.No 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 Compound (Analyte & Metabolite) Norfloxacin Nadolol Naproxine Norethindrone Nifedipine Nitrofurontoin Omeprazole Ondansetron Oxcarbazepine + 10Hydroxy Carbazepine Oxibutinine+desethyl Oxybutine Olanzapine Olmesartan Pantoprazole Pantoprazole Paroxetine Paracetamol Perindopril + Perindoprilate Perindopril + Indapamide Pioglitazone+M-III+M-IV metabolites Phenytoin Potasium Method LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS ICP-OES Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Human Urine Sensitivity (LOQ) 5.0ng/ml 0.5 ng/ml 500 ng/ml 0.1ng/ml 0.5 ng/ml 10 ng/ml 10.00ng/ml 2.51 ng/ml 51.43 ng/ml + 301.69 ng/ml 50+100 pg/ml 0.2 ng/ml 5ng/ml 5.0 ng/ml 25.67 ng/ml 0.10 ng/ml 200 ng/ml 0.5 ng/ml + 0.4 ng/ml 0.5+0.2ng/ml 20.0ng/ml+5.0ng/ml+10.0ng/ml 25ng/ml 100ug/ml

LIST OF VALIDATED METHODS
S.No 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 Compound (Analyte & Metabolite) Pramipexole Prasugrel(R138727) Projesterone Propronolol Propafenone+5Hydroxy Propafenone Quetiapine Fumerate Quinapril + Quinaprilate + Hydrochlorothiazide Quinine Ramipril + Ramiprilate Rabiprazole Ranlolagine Raloxefen+4-oh Glucoronide+6oh Glucoronide Repaglinide Ribavirin Rifaxamin Risperidone Risedronate Rivastigmine tartarate Rizatriptan Ropinarole Ropinarole Method LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Sensitivity (LOQ) 20 pg/ml 0.5 ng/ml 1.0ng/ml 0.5 ng/ml 0.2ng/ml+0.2ng/ml 1.0 ng/ml 3.50 ng/ml + 10.75 ng/ml +4.08 ng/ml 10 ng/ml 0.25ng/ml + 0.25 ng/ml 5.0ng/ml 2.0 ng/ml 10pg/ml+0.5ng/ml+0.5ng/ml 0.5 ng/ml 10.0 ng/ml 50 pg/ml 0.1ng/ml 50 pg/ml 0.2 ng/ml 0.2 ng/ml 10 pg/ml 50 pg/ml

LIST OF VALIDATED METHODS
S.No 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 Compound (Analyte & Metabolite) Rosuvastatin Salicylic acid Simvastatin+OH-Simvastatin Stavudine + Lamvudine +Nevirapine Stavudine + Lamvudine +Nevirapine Sildenafil+Piparazine Sildenafil Sertraline Slolefenacin Sumatriptan Sulfamethoxazole+Trimethoprim Tacrolimus Tadalafil Tamsulosin Terazosine Telmisartan Telmisartan+HCTZ Testosterone Tolterodine Tartrate + Hydroxy Tolterodine Topiramate Torsemide Total Estrone+Total Equilin Method LC-MS/MS HPLC-VWD LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC-VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS Biological Matrix Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Whole Blood Plasma Plasma Plasma Plasma Plasma Serum Plasma Plasma Plasma Plasma Sensitivity (LOQ) 0.53 ng/ml 2.0 µg/ml 0.2+0.1ng/ml 0.05 µg/ml + 0.051 µg/ml+0.05µg/ml 5ng/ml+5ng/ml+10ng/ml 5ng/ml+2ng/ml 0.2 ng/ml 0.2 ng/ml 0.2ng/ml 100ng/ml+20ng/ml 0.2ng/ml 3.02 ng/ml 0.10 ng/ml 0.10 ng/ml 0.5ng/ml 0.5ng/ml+2 ng/ml 1.0 ng/ml 0.05 ng/ml + 0.05 ng/ml 10 ng/ml 0.148 µg/ml 50pg/ml+50pg/ml

LIST OF VALIDATED METHODS
S.No Compound (Analyte & Metabolite) Method Biological Matrix Sensitivity (LOQ)

212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230

Tenofavir Theophylline Terbinafine Tramodal Triamcinolone acetonide Trazadone Trandolopril+Trandolaprilate Ursodiol Valsartan+Hydrochlorothiazide Valcyclovir Valcyclovir+Aciclovir Valganciclovir Venalafexine + ODesmethylvenlafaxine Voriconazole Zaleplon Zolpidem Zidovudine Zidovudine+Lamivudine+Nevirapine Ziprasidone

LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS HPLC/VWD LC-MS/MS LC-MS/MS LC-MS/MS

Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma

4.0ng/ml 300ng/ml 5ng/ml 0.5 ng/ml 20pg/ml 10 ng/ml 50 pg/ml+100 pg/ml 10 ng/ml 24.0ng/mL+2.0ng/mL 200ng/ml 1ng/ml+200ng/ml 5ng/ml 1.0 ng/ml + 2.0 ng/ml 10ng/ml

LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS

Plasma Plasma Plasma Plasma Plasma

0.30 ng/ml 1.00 ng/ml 20 ng/ml 5ng/ml+5ng/ml+10ng/ml 1.0ng/ml

LIST OF VALIDATED METHODS – TRACE METAL IONS
S.No Trace Metal Ions Method

231 232 233 234 235 236 237

Aluminium Barium Boron Calcium Lead Magnesium Silica

ICP-OES ICP-OES ICP-OES ICP-OES ICP-OES ICP-OES ICP-OES

Methods under development
S. No. Compound (Analyte & Metabolite) Method Biological Matrix Sensitivity (LOQ) TBD

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Ethinylestradiol+Cyproterone acetate Misoprostol acid Acitretin all trans+13-Cis acitretin Verapamil+Norverapamil Cholecalciferol Atavoquine Domperidone Dex Lansoprazole Rasagiline Eletriptan Apripetent Hydroxy chloroquine Pregabalin Pravastatin Darifenacin Celecoxib

LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS LC-MS/MS

Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma Plasma

5 pg/ml+200 pg/ml 5pg/ml 2 ng/ml+0.1 ng/ml 1 ng/ml+1ng/ml 0.5ng/ml 20 ng/ml 0.5ng/ml 5ng/ml 20 pg/ml 0.5ng/ml 10ng/ml 2.0ng/ml 50ng/ml 1ng/ml 20pg/ml 5ng/ml

FLD HPLC LC MS VWD TBD LOQ

: Fluorescence Detector : High Performance Liquid Chromatography : Liquid Chromatography : Mass Spectrometry : Variable Wavelength Detector : To be determined : Limit of Quantification

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