Green versatile micellar electrokinetic chromatographic method for determination of six antimicrobial and anti-inflammatory drugs in combined dosage forms

A fast reliable micellar electrokinetic methodology was investigated for the concurrent quantitation of six antimicrobial and anti-inflammatory drugs, namely, ciprofloxacin, dexamethasone, metronidazole, ornidazole, spiramycin and tinidazole. The method has the merits of rapidity, precision, and sensitivity. The separation was carried out in less than 7 min by applying a basic background electrolyte consisting of 25 mM disodium tetraborate buffer, pH 9 containing 50 mM SDS at 25 kV using photodiode array detector at 230 and 315 nm. The internal standard used during analysis was cromolyn sodium and validation was carried out following ICH guidelines. The proposed method showed linear response over the range from 0.5 to 10.0 μg mL−1 reaching limits of detection and limits of quantitation in the ranges of 0.09–0.2 μg mL−1 and 0. 27–0.6 respectively. The method's greenness was estimated using the GAPI tool where excellent greenness was concluded. Co-formulated or single-ingredient commercial preparations were investigated and the results were statistically evaluated.

[1]  M. de la Guardia,et al.  Green Analytical Chemistry , 2008 .

[2]  S. Amer,et al.  Stepwise optimization and sensitivity improvement of Green Micellar Electrokinetic Chromatography method to simultaneously determine some Fluoroquinolones and Glucocorticoids present in different binary ophthalmic formulations. , 2020, Biomedical chromatography : BMC.

[3]  S. Amer,et al.  A Two-Step Optimization Approach: Validated RP-HPLC Method for Determination of Gatifloxacin and Dexamethasone in Ophthalmic Formulation. , 2020, Journal of chromatographic science.

[4]  S. Amer,et al.  Economic chromatographic methods for simultaneous quantitation of some fluoroquinolones and corticosteroids present in different binary ophthalmic formulations , 2020 .

[5]  Reem H. Obaydo,et al.  Spectrophotometric strategies for the analysis of binary combinations with minor component based on isoabsorptive point's leveling effect: An application on ciprofloxacin and fluocinolone acetonide in their recently delivered co-formulation. , 2019, Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy.

[6]  F. Ibrahim,et al.  Green RP-HPLC method for simultaneous determination of moxifloxacin combinations: Investigation of the greenness for the proposed method , 2019, Microchemical Journal.

[7]  C. Dorn,et al.  Determination of total or free cefazolin and metronidazole in human plasma or interstitial fluid by HPLC-UV for pharmacokinetic studies in man. , 2019, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[8]  Shen-ming Chen,et al.  Biocompatible chitosan-pectin polyelectrolyte complex for simultaneous electrochemical determination of metronidazole and metribuzin. , 2019, Carbohydrate polymers.

[9]  Zhongqi Xu,et al.  Pressure-assisted electrokinetic injection stacking for seven typical antibiotics in waters to achieve μg/L level analysis by capillary electrophoresis with UV detection , 2019, Microchemical Journal.

[10]  Ahmed M. Ibrahim,et al.  Response surface and tolerance analysis approach for optimizing HPLC method , 2019, Microchemical Journal.

[11]  A. Gajda,et al.  Simultaneous determination of 45 antibacterial compounds in mushrooms - Agaricus bisporus by ultra-high performance liquid chromatography-tandem mass spectrometry. , 2019, Journal of chromatography. A.

[12]  T. Bączek,et al.  Combination of field amplified sample injection and hydrophobic interaction electrokinetic chromatography (FASI-HIEKC) as a signal amplification method for the determination of selected macrocyclic antibiotics. , 2019, Analytica chimica acta.

[13]  J. Hajšlová,et al.  Multiclass analysis of antimicrobial drugs in shrimp muscle by ultra high performance liquid chromatography-tandem mass spectrometry , 2018, Journal of food and drug analysis.

[14]  M. Tobiszewski,et al.  Green Analytical Chemistry: Past, Present and Perspectives , 2019, Green Chemistry and Sustainable Technology.

[15]  Thi Thao Ta,et al.  Speciation Analysis of Arsenic Compounds by HPLC-ICP-MS: Application for Human Serum and Urine , 2018, Journal of analytical methods in chemistry.

[16]  M. Fouad,et al.  Densitometric and UV-Spectrophotometric Methods for Simultaneous Determination of Spiramycin adipate in Binary Mixture with Oxytetracycline-HCl or Tetracycline-HCl , 2018, International Research Journal of Pure and Applied Chemistry.

[17]  E. El-Kimary,et al.  Sensitive inexpensive chromatographic determination of an antimicrobial combination in human plasma and its pharmacokinetic application. , 2018, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[18]  P. Gortáres-Moroyoqui,et al.  Simultaneous quantification of antibiotics in wastewater from pig farms by capillary electrophoresis. , 2018, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[19]  F. Belal,et al.  Simultaneous Determination of Five Coccidiostats in Veterinary Powders, Feed Premixes, and Baby Food by Micellar Electrokinetic Chromatography: Application to Chicken Tissues and Liver , 2018, Food Analytical Methods.

[20]  J. Veuthey,et al.  High‐resolution separation of monoclonal antibodies mixtures and their charge variants by an alternative and generic CZE method , 2018, Electrophoresis.

[21]  V. Maslarska,et al.  HPLC method for simultaneous determination of metronidazole and preservatives in vaginal gel formulation , 2018, Acta Chromatographica.

[22]  Ghoufran Kawas,et al.  Analytical Methods of Ciprofloxacin and its Combinations Review , 2018 .

[23]  Samah F. El-Malla,et al.  Factor Space Analysis and Dual Wavelength Spectrophotometric Methods for Simultaneous Determination of Norfloxacin and Tinidazole in Tablet , 2018 .

[24]  J. Płotka-Wasylka,et al.  A new tool for the evaluation of the analytical procedure: Green Analytical Procedure Index. , 2018, Talanta.

[25]  A. Mahmoudi Efficient and simple HPLC method for spiramycin determination in urine samples and in pharmaceutical tablets , 2018 .

[26]  C. Oliveira,et al.  Development of Micellar HPLC-UV Method for Determination of Pharmaceuticals in Water Samples , 2018, Journal of analytical methods in chemistry.

[27]  David S. Wishart,et al.  DrugBank 5.0: a major update to the DrugBank database for 2018 , 2017, Nucleic Acids Res..

[28]  R. Sunil,et al.  RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FLUCONAZOLE AND TINIDAZOLE IN TABLET DOSAGE FORM , 2018 .

[29]  Debin Zhu,et al.  Sensitive Voltammetric Detection of Metronidazole Based on Three-Dimensional Graphene-Like Carbon Architecture/Polythionine Modified Glassy Carbon Electrode , 2018 .

[30]  Satish A. Patel,et al.  DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE ESTIMATION OF ORNIDAZOLE IN PHARMACEUTICAL FORMULATION , 2017 .

[31]  N. Youssef,et al.  Greener Thin-Layer Chromatographic Solvents for the Determination of Pantoprazole Sodium Sesquihydrate, Metronidazole and Clarithromycin in Pharmaceutical Formulations Used as Triple Therapy in Helicobacter Infection , 2017, JPC – Journal of Planar Chromatography – Modern TLC.

[32]  Y. Nikodimos,et al.  Electrochemical Behaviour of Tinidazole at 1,4-Benzoquinone Modified Carbon Paste Electrode and Its Direct Determination in Pharmaceutical Tablets and Urine by Differential Pulse Voltammetry , 2017, Journal of analytical methods in chemistry.

[33]  Farrel Lisa Gauncar DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN PRESENCE OF ORNIDAZOLE IMPURITY IN COMBINED PHARMACEUTICAL DOSAGE FORM , 2017 .

[34]  Farrel Lisa Gauncar DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF OFLOXACIN AND ORNIDAZOLE IN COMBINED DOSAGE FORM USING SIMULTANEOUS EQUATION METHOD , 2017 .

[35]  N. Abdelwahab,et al.  Three New Methods for Resolving Ternary Mixture with Overlapping Spectra: Comparative Study. , 2017, Chemical & pharmaceutical bulletin.

[36]  M. Tajne,et al.  Simultaneous Determination of Fluconazole and Tinidazole in Combined Dose Tablet using High Performance Thin Layer Chromatography , 2017 .

[37]  C. Cruces‐Blanco,et al.  Evaluation of the combination of micellar electrokinetic capillary chromatography with sweeping and cation selective exhaustive injection for the determination of 5-nitroimidazoles in egg samples. , 2016, Food chemistry.

[38]  M. Aucamp,et al.  A NOVEL RP-HPLC METHOD FOR THE DETECTION AND QUANTIFICATION OF CLARITHROMYCIN OR SPIRAMYCIN IN BULK DRUG SAMPLES AND DOSAGE FORMS , 2016 .

[39]  F. Belal,et al.  Analysis of four antimigraine drugs in two ternary mixtures by sweeping-micellar electrokinetic chromatography with retention factor gradient effect and dynamic pH junction , 2016 .

[40]  N. Abdelwahab,et al.  Different chromatographic methods for simultaneous determination of diloxanide furoate, metronidazole and its toxic impurity , 2016, Journal of the Iranian Chemical Society.

[41]  M. T. Ansari,et al.  Development and application of spectrophotometric method for quantitative determination of Metronidazole in pure and tablet formulations , 2016 .

[42]  S. Fraihat Green methods for the determination of nitrite in water samples based on a novel diazo coupling reaction , 2016 .

[43]  Ashutosh Kumar Singh,et al.  Improved UV Spectrophotometric Method for Precise, Efficient and Selective Determination of Dexamethasone in Pharmaceutical Dosage Forms , 2015 .

[44]  D. S. Bol’shakov,et al.  Identification and determination of antibacterial substances in drugs by capillary electrophoresis , 2015, Journal of Analytical Chemistry.

[45]  Mohammad Zameeruddin REVIEW ON ANALYTICAL METHOD VALIDATION OF NITROIMIDAZOLES , 2014 .

[46]  U. Pyell,et al.  Robust analysis of the hydrophobic basic analytes loratadine and desloratadine in pharmaceutical preparations and biological fluids by sweeping-cyclodextrin-modified micellar electrokinetic chromatography. , 2013, Journal of chromatography. A.

[47]  J. Mak,et al.  Significant Reduction of Brain Cysts Caused by Toxoplasma gondii after Treatment with Spiramycin Coadministered with Metronidazole in a Mouse Model of Chronic Toxoplasmosis , 2012, Antimicrobial Agents and Chemotherapy.

[48]  J. Powers,et al.  Fluoroquinolone-resistant Campylobacter species and the withdrawal of fluoroquinolones from use in poultry: a public health success story. , 2007, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[49]  P. Poulet,et al.  Concentrations and in vivo antibacterial activity of spiramycin and metronidazole in patients with periodontitis treated with high-dose metronidazole and the spiramycin/metronidazole combination. , 2005, The Journal of antimicrobial chemotherapy.

[50]  L. Schneider,et al.  Ciprofloxacin in combination with metronidazole , 1988, Infection.

[51]  Eric R. Ziegel,et al.  Statistics and Chemometrics for Analytical Chemistry , 2004, Technometrics.

[52]  M. Riekkola,et al.  Terminology for analytical capillary electromigration techniques (IUPAC Recommendations 2003) , 2004 .

[53]  P. Roland,et al.  Topical Ciprofloxacin/Dexamethasone is Superior to Ciprofloxacin Alone in Pediatric Patients with Acute Otitis Media and Otorrhea through Tympanostomy Tubes , 2003, The Laryngoscope.

[54]  S. Batra,et al.  Ciprofloxacin-tinidazole combination, fluconazole- azithromicin-secnidazole-kit and doxycycline- metronidazole combination therapy in syndromic management of pelvic inflammatory disease: a prospective randomized controlled trial. , 2003, Indian journal of medical sciences.

[55]  H. Wätzig,et al.  Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications , 1998, Electrophoresis.

[56]  K. Altria,et al.  Approaches to optimisation of precision in capillary electrophoresis , 1995 .

[57]  D. Goodall,et al.  Analysis of anthraquinone sulphonates: Comparison of capillary electrophoresis with high-performance liquid chromatography , 1993 .

[58]  H. Issaq,et al.  The effect of electric field strength, buffer type and concentration on separation parameters in capillary zone electrophoresis , 1991 .

[59]  H. Lode,et al.  Pharmacokinetics and serum bactericidal activities of quinolones in combination with clindamycin, metronidazole, and ornidazole , 1990, Antimicrobial Agents and Chemotherapy.

[60]  S. Terabe Electrokinetic chromatography: An interface between electrophoresis and chromatography , 1989 .