Chromatograph is a specific analytical technique to estimate quantitatively and qualitatively the content of several drug products and the contaminants present therein. This technique is based on evaluating the respective anions and cations. It is very selective and works on the basis of the specific characteristics of conductivity of the analytes.
Ever since Nitrosamine impurities were reported in drug products, this technique has become a hot topic in any Quality Control and Analytical Research Lab for the estimation of the precursors of Nitrosamine impurities (Nitrites and Nitrates) in the water used in the manufacturing process or which is added in injectables or syrups.
Studies for Extractables (USP <1663>) and Leachables (USP <1664>) are not completed without studying the anions and cations that are prone to be present.
Ion Chromatograph is used to estimate the Bromate (BrO3−) in packaged drinking water as per IS 14543. Bromate is a disinfection byproduct formed during the chemical oxidation of water containing bromide. Due to the carcinogenic effect of bromate, its maximum permissible concentration in packaged drinking water has been set to 10 μg/L by the World Health Organization.
This technique is also quite sensitive, precise, and reproducible for the estimation of fluoride in toothpaste and the raw materials used for it. Ion Chromatograph is widely used to estimate the ions in pharmaceuticals or excipients but not limited to following;
Applications of Ion Chromatograph in the Pharmaceutical Industry
| Pharmaceutical/Excipient | Analyte | Pharmaceutical/Excipient | Analyte |
|---|---|---|---|
| Acamprosate calcium | Acetate | Glycine carbonate, sodium salt | Carbonate |
| Acifluorfen, sodium | Acetate | Glimepiride | Trans-4-methylcyclohexylamine |
| Adrenaline | Adrenaline | Guaifenesin | Epichlorohydrin |
| Amisulpride | Dimethyl and diethyl sulfate | Heparin sodium | Glucosamine and galactosamine |
| Anticoagulation solution | Phosphate, citrate | Ibandronic acid sodium | Ibandronate, phosphite, phosphate |
| Arsenic trioxide | Arsenate, arsenite | Indinavir sulfate | Ethyl sulfate |
| Atovaquone | Acetate | Indomethacin sodium | 2-ethylhexane acid |
| Atorvastatin calcium salt | Cyanide, tetrabutylammonium | Irbesartan | Cyanide, azide |
| Sulfobutylether-ß-cyclodextrin | ß-cyclodextrin | Ibuprofen | Ibuprofen, valerophenone |
| Bethanechol chloride | Bethanechol, sodium, calcium, decomposition product (HPTA) | Lamotrigine | Cyanide |
| Bromide salt | Chloride | Lanthanum carbonate | Nitrate |
| Busulfan | Methanesulfonic acid | Levetiracetam | Tetrabutylammonium |
| Calcium gluconate | Oxalate | Levofloxacin | Fluoride |
| Calcium salt | Borate | Linezolid | Morpholine |
| Camphorsulfonic acid | Camphorsulfonic acid | Losartan potassium | Azide |
| Carbamazepine | Chloride bromide | Meropenem | EDTA, dimethylamine |
| Carbidopa | EDTA, hydrazine, sodium disulfite | Metformin hydrochloride | Dimethylamine |
| Cefadroxil | Cefadroxil | Mono-sulfiram (tetmosol) | Cyanide |
| Cefixime | Chloride | Naproxen | Chloride |
| Cefdinir | Iron, EDTA | Montelukast sodium | Methanesulfonic acid, acetate |
| Cefepime hydrochloride | N-methyl-pyrrolidinium | Multivitamin tablets | Cations, Vitamin C |
| Ceftazidime sodium | Sodium | Mycophenolate mofetil | Morpholine |
| Clopidogrel besylate | Anions, carbonate, cations | Nebivolol hydrochloride | Monomethylamine |
| Colesevelam | Quaternary alkylamines | Neomycin sulfate | Neomycin |
| Copovidone | EP Acetate, formate | Oxaliplatin | Chloride |
| Dasatinib | Ethylenediamine | Pioglitazone hydrochloride | Piperidine |
| Dextromethorphan HBr | Formic acid | Piperacillin | Chloride |
| (2,3-Dichlorophenyl) oxoacetonitrile | Cyanide, tetrabutylammonium | Piperazine | Piperazine, N-methylpiperazine |
| Diclofenac sodium | Sodium, potassium | RA-Thermoseal toothpaste | Potassium, zinc |
| Dicyclopropylmethylamine | Dicyclopropylmethylamine | Ribitol | Ribitol (adonitol) |
| Doxazosin, methanesulfonic acid | Bromide | S-Adenosyl methionine | Sulfate |
| Drospirenone | Propargyl alcohol | Sevelamer | Binding capacity of phosphate |
| Enoxaparin sodium | Sulfate | Suxamethonium chloride | Choline chloride |
| Esomeprazole magnesium | Tartrate | Tadalafil | Methanolic methylamine |
| Febuxostat | Hydroxylamine | Terbinafine hydrochloride | Monomethylamine, Tetrabutylammonium |
| Felodipine | Silicate, sodium | Topiramate | Carbohydrates, sulfate and sulfamate |
| Fenofibrate | Sodium lauryl sulfate (SLS) | Triclosan | Potassium |
| Ferumoxide (contrast enhancer) | Citrate | Timolol maleate | Chlorite |
| Fluorouracil (also fluoruracil) | Fluoride | Varenicline tartrate salt | Trifluormethanesulfonic acid |
| Gabapentin | Chloride | Voriconazole | Camphorsulfonic acid |
| Gadopentetate dimeglumine | Gadolinium | Zingisol | Potassium and zinc |
| Gentamicin sulfate | Gentamicin | Zoledronic acid | Phosphite, phosphate |
