Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Separation and Determination of Paracetamol and Codeine Phosphate in Pharmaceutical Preparation by using High Performance Liquid Chromatography


Affiliations
1 Department of Chemistry, Faculty of Science, University of Aleppo, Syrian Arab Republic
     

   Subscribe/Renew Journal


Accurate and precise high performance liquid chromatography (HPLC) method was developed for the determination of Paracetamol (Par) and Codeine phosphate (Cod) in pharmaceutical formulations. The chromatographic separation was achieved with acetonitrile: phosphoric acid (pH = 2.8) in ratio of 35:65 (v/v) as mobile phase on a Shim-pack clc-C8 column (25 cm x 4.6 mm i.d., 5 μm) with UV detection at 212 nm, pump flow rate 1.0 mL/min and sample injection volume 20 μL. The analysis time was < 8 min. The method was validated with respect to linearity, precision, accuracy, selectivity and specificity. The calibration curves showed good linearity over the concentration range of (3 - 600) μg/mL and (1 - 800) μg/mL for (Par) and (Cod) respectively in presence of methyl paraben (MP) as internal standard. The proposed method was successfully applied to analysis individual or mixture of (Par) and (Cod) in Syrian trademark drugs. All studied samples showed that the drug levels were conformed to united state pharmacopeia (USP) legislation. Finally, the described chromatographic procedure here is accurate, precise, selective and suitable for routine quality control analysis and stability tests.

Keywords

HPLC, Paracetamol, Codeine Phosphate.
Subscription Login to verify subscription
User
Notifications
Font Size


  • United State Pharmacopeia 34. 2011.

  • Martindal the Complete Drug Reference 35. 2007.

  • Thuy DT, Hoang VD. Simultaneous Determination of Paracetamol and Codeine Phosphate In Combined Tablets by First-Order Derivative and Ratio Spectra First-Order Derivative UV Spectrophotometry. Asian J. Research Chem. 2009; 2(2): 143-147.

  • Elsayed MA, Belal SF, Elwalily AM, Abdine H. Spectrophotometric Determination of Acetaminophen, Salicylamide and Codeine Phosphate in Tablets. Analyst Journal. 1979; (104): 620-625.

  • Dinç E, Baleanu D, Onur F. Simultaneous Spectrophotometric Analysis of Codeine Phosphate Acetylsalicylic Acid and Caffeine in Tablets by Inverse Leastsquares and Principal Component Regression Techniques. Analytical Letters. 2014; 35(3): 545-558.

  • Vojta J, Hanzlík P, Jedliˇcka A, Coufal P . Separation and Determination of Impurities in Paracetamol, Codeineand Pitophenone in The Presence of Fenpiverinium in Combined Suppository Dosage Form. Journal of Pharmaceutical and Biomedical Analysis. 2015;102: 85-92.

  • Schmidt AH. Validated HPLC Method for the Determination of Residues of Acetaminophen, Caffeine, and Codeine Phosphate on Swabs Collected from Pharmaceutical Manufacturing Equipment in Support of Cleaning Validation. Journal of Liquid Chromatography & Related Technologies. 2006; 29(11): 1663-1673.

  • Maslarska V, Tencheva J. Simultaneous Determination and Validation of Paracetamol and Codeine Phosphate in Pharmaceutical Preparation by RP-HPLC. International Journal of Pharmacy and Pharmaceutical Sciences. 2013; 5(2): 417-419.

  • Belal F, Omar MA, Derayea S, Zayed S, Hammad MA, Saleh SF. Simultaneous Determination of Paracetamol, Caffeine and Codeine in Tablets and Human Plasma by Micellar Liquid Chromatography. European Journal of Chemistry. 2015; 6(4): 468-474.

  • Garazhian E, Shishehbore MR. A New Sensitive Sensor for Simultaneous Differential Pulse Voltammetric Determination of Codeine and Acetaminophen Using a Hydroquinone Derivative and Multiwall Carbon Nanotubes Carbon Paste Electrode. International Journal of Analytical Chemistry. 2015.

  • Santos AM, Silva TA, Vicentini FC, Fatibello O. Flow Injection Analysis System with Electrochemical Detection for The Simultaneous Determination of Nanomolar Levels of Acetaminophen and Codeine. Arabian J. of Chemistry. 2017.

  • Santos AM, Vicentini FC, Deroco PB, Rocha RC, Fatibello O. Square-Wave Voltammetric Determination of Paracetamol and Codeine in Pharmaceutical and Human Body Fluid Samples Using a Cathodically Pretreated Boron-Doped Diamond Electrode. J. Braz. Chem. Soc. 2015; 10(26).

  • Deroco PB, Vicentini FC, Fatibello O. An Electrochemical Sensor for the Simultaneous Determination of Paracetamol and Codeine Using a Glassy Carbon Electrode Modified with Nickel Oxide Nanoparticles and Carbon Black. Electroanalysis. 2015; 27: 2214-2220.

  • Hasanpour F, Taei M, Tahmasebi S. Ultra-Sensitive Electrochemical Sensing of Acetaminophen and Codeine in Biological Fluids Using Cuo/CuFe2O4 Nanoparticles as a Novel Electrocatalyst. J.of Food and Drug analysis. 2017.


Abstract Views: 162

PDF Views: 0




  • Separation and Determination of Paracetamol and Codeine Phosphate in Pharmaceutical Preparation by using High Performance Liquid Chromatography

Abstract Views: 162  |  PDF Views: 0

Authors

Saad Antakli
Department of Chemistry, Faculty of Science, University of Aleppo, Syrian Arab Republic
Leon Nejem
Department of Chemistry, Faculty of Science, University of Aleppo, Syrian Arab Republic
Duha Shawa
Department of Chemistry, Faculty of Science, University of Aleppo, Syrian Arab Republic

Abstract


Accurate and precise high performance liquid chromatography (HPLC) method was developed for the determination of Paracetamol (Par) and Codeine phosphate (Cod) in pharmaceutical formulations. The chromatographic separation was achieved with acetonitrile: phosphoric acid (pH = 2.8) in ratio of 35:65 (v/v) as mobile phase on a Shim-pack clc-C8 column (25 cm x 4.6 mm i.d., 5 μm) with UV detection at 212 nm, pump flow rate 1.0 mL/min and sample injection volume 20 μL. The analysis time was < 8 min. The method was validated with respect to linearity, precision, accuracy, selectivity and specificity. The calibration curves showed good linearity over the concentration range of (3 - 600) μg/mL and (1 - 800) μg/mL for (Par) and (Cod) respectively in presence of methyl paraben (MP) as internal standard. The proposed method was successfully applied to analysis individual or mixture of (Par) and (Cod) in Syrian trademark drugs. All studied samples showed that the drug levels were conformed to united state pharmacopeia (USP) legislation. Finally, the described chromatographic procedure here is accurate, precise, selective and suitable for routine quality control analysis and stability tests.

Keywords


HPLC, Paracetamol, Codeine Phosphate.

References