Simultaneous Determination of Dextromethorphan and Promethazine in Pharmaceutical Syrups by Rapid HPLC Method
DOI:
https://doi.org/10.37285/ijpsn.2015.8.2.5Abstract
A simple, precise and accurate method is validated for the simultaneous determination of two nitrogenous compounds dextromethorphan hydrobromide and promethazine hydro-chloride, which are commonly used as active ingredients in pharmaceutical syrups. The chromatographic conditions comprised of a classical C8-type stationary phase (250 × 4.6 mm, 5 μm) with a mobile phase consisting of 3 g of sodium lauryl sulfatein a mixture of 400 ml of water and 600 ml of acetonitrile along with 0.5 g of ammonium nitrate as additional agent. The solution pH 2.0 was adjusted with glacial acetic acid. The flow rate was 1 ml/min; the detection was carried out at 280 nm under temperature of 25o. The retention time of dextromethorphan was 8.5 min and 9.9 min for promethazine. The method was validated for specificity, accuracy, precision and linearity. The results indicate that the drugs are susceptible to photo-degradation. All the peaks of degraded products were resolved from the two active pharmaceutical ingredients with significant different retention times.
Downloads
Metrics
Keywords:
Dextromethorphan, Promethazine, Syrups, assay validation.
Downloads
Published
How to Cite
Issue
Section
References
Al-Rimawi F (2010). Normal-Phase Lc Method for Simultaneous Analysis of Pseudophedrine Hydrochloride, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate and Paracetamol in Tablet Formulations. Saudi Pharmaceutical Journal . 18(2): 103-106.
Bosáková Z, Kloučková I and Tesařová E (2002). Study of the Stability of Promethazine Enantiomers By Liquid Chromatography Using a Vancomycin-Bonded Chiral Stationary Phase. Journal of Chromatography British Pharmacopeia .770(1-2): 63-69 .
Daniel D, Gebhardt I and Gutz R (2003). Flow Injection Spectroelectro Analytical Method for the Determination of Promethazine Hydrochloride in Pharmaceutical Preparations. Analytica ChimicaActa. 494(1): 215-224.
Elmorsy K, Hassan HNA, Gehad GM and Seleim AA (2010). Carbon Paste and Pvc Electrodes for the Flow Injection Potentiometric Determination of Dextromethorphan. Talanta . 81(1-2): 510-515.
Gomez MR, Olsina RA, Martı́nez LD and Silva MF (2002). Simultaneous Determination of Dextromethorphan, Diphenhydramine and Phenylephrine in Expectorant and Decongestant Syrups by Capillary Electrophoresis. Journal of Pharmaceutical and Biomedical Analysis. 30(3): 791-799.
Lara FJ, García-Campaña AM, Alés-Barrero F and Bosque-Sendra JM (2005). Determination of Phenothiazines in Pharmaceutical Formulations and Human Urine using Capillary Electrophoresis with Chemiluminescence Detection. AnalyticaChimica Acta . 535(1-2): 101-108.
Louhaichi MR, Jebali S, Loueslati MH, Adhoum N and Monser L (2009). Simultaneous Determination of Pseudoephdrine, Pheniramine, Guaifenisin, Pyrilamine, Chlo- Rpheniramine and Dextromethorphan in Cough and Cold Medicines by High Performance Liquid Chromatography. Talanta. 78(3): 991-997.
Marco JP, Borges KB, Teixeira Tarley CR, Ribeiro ES and Pereira AC (2013). Development of a Simple, Rapid and Validated Square Wave Voltametric Method for Determination of Promethazine in Raw Material and Pharmaceutical Formulation using DNA Modified Multiwall Carbon Nanotube Paste Electrode. Sensors and Actuators B: Chemical . 177: 251-259.
Pereira PF, Marra MC, Cunha RR, DaSilva WP, Abarza Munoz RA, and Richter EM (2014). Two Simple and Fast Electrochemical Methods for Simultaneous Determination of Promethazine and Codeine. Journal of Electroanalytical Chemistry . 713: 32-38.
Rauha JP, Salomies H, and Aalto M (1996). Simultaneous Determination of Bromhexine Hydrochloride and Methyl and Propyl P-Hydroxybenzoate and Determination of Dextromethorphan hydrobromide in Cough-Cold Syrup by High-Performance Liquid Chromatography. Journal of Pharmaceutical and Biomedical Analysis. 15(2): 287-293.
Ruedas Rama MJ, Ruiz Medina A and Molina Dı́az A (2004). Bead Injection Spectroscopy-Flow Injection Analysis (Bis-Fia): An Interesting Tool Applicable to Pharmaceutical Analysis: Determination of Promethazine and Trifluoperazine. Journal of Pharmaceutical and Biomedical Analysis. 35(5): 1027-1034.
Saif MJ and Anwa J (2005). A New Spectrophotometric Method for the Determination of Promethazine-Hcl from Pure and Pharmaceutical Preparations. Talanta,. 67(5): 869-872.
Saleh TA, Abulkibash AM and Ibrahim AE (2012). Portable System of Programmable Syringe Pump with Potentiometer for Determination of Promethazine in Pharmaceutical Applications. Saudi Pharmaceutical Journal. 20(2): 155-160.
Shahid Ali M, Ghori M, Rafiuddin S and Khatri AR (2007). A New Hydrophilic Interaction Liquid Chromatographic (Hilic) Procedure for the Simultaneous Determination of Pseudoephedrine Hydrochloride (Psh), Diphenhydramine Hydrochloride (Dph) and Dextromethorphan Hydrobromide (Dxh) in Cough-Cold Formulations. Journal of Pharmaceutical and Biomedical Analysis. 43(1): 158-167.
Tan HSI, and Kolmonpunporn M (1998). Second-Derivative Spectrophotometric Determination of Mixtures of Phenylpropanolamine Hydrochloride and Dextromethorphan Hydrobromide in Some Pharmaceutical Preparations. AnalyticaChimicaActa . 226(1): 159-164.
Tantishaiyakul V, Poeaknapo C, Sribun P and Sirisuppanon K (1998). Simultaneous Determination of Dextromethorphan Hbr And Bromhexine Hcl in Tablets by First-Derivative Spectrophotometry. Journal of Pharmaceutical and Biomedical Analysis. 17(2): 237-243.
Tedesco D, Di Pietra AM, Rossi F, Garagnani M, Del Borrello E, Bertucci C, and Andrisano V (2013). Determination of Dextromethorphan and Levomethorphan in Seized Heroin Samples by Enantio Selective Hplc and Electronic CD. Journal of Pharmaceutical and Biomedical Analysis . 81-82: 76-79.
Wilson TD, Jump WG, Neumann WC and Martin TS (1993). Validation of Improved Methods for High-Performance Liquid Chromatograpic Determination of Phenylpropanolamine, Dextromethorphan, Guaifenesin and Sodium Benzoate in A Cough-Cold Formulation. Journal of Chromatography. A 641(2): 241-248.
Zhang Q, Zhan X, Li C, Lin T, Li L, Yin X, He N and Shi Y (2005). Determination of Promethazine Hydrochloride and its Preparations by Highly Accurate Nephelometric Titration. International Journal of Pharmaceutics. 302(1-2): 10-17.
