RP-HPLC method for estimation of tramadol hydrochloride and paracetamol in pharmaceutical formulation

T Hemant Kumar; C Kasi Krishna Prajna; K Varaprasad Rao; Y Srinivasa Rao

doi:10.30574/gscbps.2019.8.1.0091

Authors

T Hemant Kumar Vignan Institute of Pharmaceutical Technology, Duvvada, Vishakapatnam, Andhra Pradesh, India.
C Kasi Krishna Prajna Vignan Institute of Pharmaceutical Technology, Duvvada, Vishakapatnam, Andhra Pradesh, India.
K Varaprasad Rao Vignan Institute of Pharmaceutical Technology, Duvvada, Vishakapatnam, Andhra Pradesh, India.
Y Srinivasa Rao Vignan Institute of Pharmaceutical Technology, Duvvada, Vishakapatnam, Andhra Pradesh, India.

DOI:

https://doi.org/10.30574/gscbps.2019.8.1.0091

Keywords:

RP-HPLC, Tramadol hydrochloride, Paracetamol

Abstract

A simple, rapid and sensitive RP-HPLC method was developed for the quantitative determination of tramadol hydrochloride and paracetamol in combined tablet dosage form. The chromatographic analysis was carried out on enable C18G column (250 x 4.6 mm, 5 μm) with mobile phase containing 1 % glacial acetic acid: acetonitrile (50:50 v/v). The flow rate of mobile phase was 1.0 mL/min and effluents were monitored at 272 nm. The retention times of tramadol hydrochloride and paracetamol were 2.032 min and 2.711 min, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity and robustness. The method was found to simple, rapid and sensitive and was successfully applied to the estimation of tramadol hydrochloride and paracetamol in combined dosage form.

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References

Tripathi KD. (2006). Essentials of Pharmacology, sixth edition, Autocoids and Related drugs, 182.

Rang, D, Ritter, Flower and Henderson. (2007). Rang and Dale’s Pharmacology, fifth edition, The Nervous system, Drug dependence drug abuse, 607.

Gharge D and Dhabale P. (2010). Simultaneous estimation of tramadol hydrochloride and paracetamol by UV spectrophotometric method from tablet formulation. International Journal of PharmTech Research, 2, 1119-1123.

Ahmad M, El-Zinati and Abdel-Latif MS. (2015). Simultaneous determination of paracetamol and tramadol in pharmaceutical tablets by derivative UV-Vis absorption spectrophotometry. Open Analytical Chemistry Journal, 8, 1-6.

Srinivasan KK, Alex J, Shirwaikar AA, Jacob S, Sunilkumar MR and Prabhu SL.(2007). Simultaneous determination of paracetamol and tramadol in pharmaceutical tablets by derivative UV-Vis absorption spectrophotometry. Indian Journal of Pharmaceutical Sciences, 69, 540-545.

Shukla R, Shivkumar R and Shivan KN. (2011). Development of a UV-spectrophotometric method for the simulataneous determination of tramadol hydrochloride and paracetamol in bulk and marketed product. Bulletin of Pharmaceutical Research, 1, 62-66.

Zarei AR, Mardi K and Chalavi S. (2013). Simultaneous spectrophotometric determination of tramadol and acetaminophen in pharmaceutical formulations using H-Point standard addition method. Jordan Journal of Pharmaceutical Sciences, 6, 48-55.

Sawant R, Bhangale L, Joshi R and Lanke P. (2010). Validated spectrophotometric methods for simultaneous estimation of paracetamol, domperidone and tramadol HCl in pure and tablet dosage form. Journal of Chemical Metrology, 4, 21-27.

Narayan S, Kumar P, Sindhu RK, Tiwari A and Ghosh M. (2009). Simultaneous analysis of paracetamol and tramadol – Analytical method development & validation. Der Pharma Chemica, 1, 72-78.

Pradip BN, Emanual PM and Guatambhai. (2012). Simultaneous Estimation of Tramadol Hydrochloride, Paracetamol and Domperidone in Pharmaceutical Formulation by Thin-Layer Chromatographic- Densitometric Method. Journal of Chromatography and Separation Techniques, 3(5), 3- 6.

Roosewelt C, Harihrishnan N, Gunasekaran V, Chandrasekaran S, Haribaskar V and Prathap B.(2010). Simultaneous Estimation and Validation of Tramadol and Paracetamol by HPTLC in Pure and Pharmaceutical Dosage Form. Asian Journal of Chemistry, 22(2), 850-854.

Prafulla AP, Mahadev MV and Sunil DR. (2010). Validated HPTLC Method for Simultaneous Quantitation Of Paracetamol, Tramadol And Aceclofenac In Tablet Formulation, Der Pharmacia Lettre, 2(6), 28-36.

Sam Solomon WD, Vijai Anand PR, Rajesh S, Sivakumar R and Venkatnarayanan. (2010). Application of TLC- Densitometry Method for Simultaneous Estimation of Tramadol HCl and Paracetamol in Pharmaceutical Dosage Forms; International Journal of Chem Tech Research, 2(2), 1188-1193.

Karunakaran K, Navaneethan G and Elango KP. (2012). Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Determination of Paracetamol, Tramadol HCl and Domperidone in a Combined Dosage Form. Tropical Journal of Pharmaceutical Research, 11(1), 99-106.

Chandra P, Atul SR, Sathiyanarayanan L and Kakasaheb RM. (2012). Application of HPLC for the Simultaneous Determination of Aceclofenac, Paracetamol and Tramadol Hydrochloride in Pharmaceutical Dosage Form. Scientia Pharmaceutica, 80, 337-351.

Saha S, Dey BK, Chakraborty S and Choudhury T. (2013). Development Of Reverse Phase High Performance Liquid Chromatographic Method And Method Validation Of Paracetamol By Using Economical Single Mobile Phase. Journal of Applied Pharmaceutical Research, 10(1), 24-29.

Swamy DK, Sirisha K,.Dhanuja G and Adukondalu D.(2018). New RP-HPLC method for the simultaneous estimation of paracetamol and tramadol hydrochloride in bulk and tablet dosage form. International Research Journal of Pharmacy, 9(6), 82-86.

Belal T, Awad T and Clark CR. (2009). Determination of Paracetamol and Tramadol hydrochloride in pharmaceutical mixture using HPLC and GC-MS. Journal of Chromatographic Science, 47, 849-854.

International Conference on Harmonization, Harmonized Tripartite Guideline. (2005). Validation of Analytical Procedures. Text and Methodology. Q2 (R1).