Asian Journal of Research in Chemistry

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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Tramadol Hydrochloride and Diclofenac Sodium in Synthetic Mixture


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1 Department of Pharmaceutical Analysis, Centre for Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India
     

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A simple, accurate, and rapid reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Tramadol Hydrochloride (TRM) and Diclofenac sodium (DIC) in synthetic mixture. The separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH, 6.0) (68:32, v/v). The column used was Phenomenex C18, (250 mm x 4.6 mm i.d., 5 μm) with flow rate 1.2 ml/min using PDA detection at 219 nm. The method was linear over a concentration range 2 - 30 μg/ml for both drugs. The retention time of Tramadol hydrochloride and Diclofenac sodium were found to be 6.30 min and 8.35 min respectively. Results of analysis were validated statistically and by recovery studies. The mean recovery was 99.29 ± 0.54 and 99.03 ± 0.45 for TRM and DIC respectively. The limit of detection (LOD) and the limit of quantification (LOQ) for TRM and DIC were found to be 0.6586 and 1.9956 µg/ml and 0.6169 and 1.8695 μg/ml, respectively. The results of the study showed that the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and also useful for the routine determination of TRM and DIC in mixture.

Keywords

Tramadol Hydrochloride, Diclofenac Sodium, RP-HPLC, Validation
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  • Maryadele, J. O’Neil, Eds., In; The Merck Index. An Encyclopedia of Chemicals, Drugs and Biological, 14th Edn, Merck & Co., Inc., Whitehouse Station. NJ, 2006, p. 1644.

  • Indian Pharmacopoeia. Vol. III. The Controller of Publication. 6th ed. Govt. of India. New Delhi. 2010, p. 2245-2247.

  • British Pharmacopoeia. Vol. III. Stationary office. London Medicines and Healthcare product regulatory agency, 2010, p. 3147.

  • Shetty KN, Ramachar T, Chakravarthy I. Simple spectrophotometric estimation of Tramadol hydrochloride in pharmaceutical formulation. Chemical Science Transaction, 1(2); 2012: 317-320.

  • Rajitha, Prashanthi S, Ramsubha K. Extractive Spectrophotometric determination of Tramadol HCl in pure and pharmaceutical dosage form. International Journal of Pharmacy. 3; 201:114-117.

  • Khaggeswar B, Reddy R, Bharadwaj R. New validation, U.V. Spectrophotometric method for the estimation of Rebamipide and Tramadol in bulk and dosage form, Scholar Research Library. 3(1); 2011: 298-306.

  • Ghaege D, Dhabale P. Simultanious estimation of Tramadol and Paracetamol by U.V. Spectrophotometric method for tech. formulation. International Journal of Pharmacy. 2(2); 2010:1119-1123.

  • Sawant R, Bhangale L, Joshi R. Validation of spectrophotometric method for simultaneous estimation of paracetamol, domeperidone tramadol. Journal of Chemical Metrology. 4(1); 2010:21-27.

  • Nobilis M, Kopecky J, Kvetina J. HPLC determination of Tramadol HCl and its O-desmethylated metabolite in blood plasma application to bio equivalance study in human, Journal of Chromatography. A949; 2002: 11-22.

  • Chandra P, Rathore A, Lohidasan S, Application of HPLC for simultaneous determination of Aceclofenac, Paracetamol and Tramadol HCl in pharmaceutical dosage form, Science Pharmaceutica. 80; 2012: 337–351.

  • Karynakaran K, Navaneethan G. and Elango KP. Development and validation of stability indicating RP-HPLC metod for simultaneous determination of Paracetamol, Tramadol HCl and Domperidone in combine dosage form. Tropical Journal of pharmaceutical Research. 11(1); 2012: 99-106.

  • Belal T, Awad T. and RandallClark C. Determination of Paracetamol and Tramadol HCl in pharmaceutical mix using HPLC and GCMS. Journal of Chromatographic Science. 47; 2009:849-854.

  • Fatima mary titus J, Thenmozhi J. Shridharan D. HPTLC Method for simultaneous estimation of Tramadol HCl and Paracetamol in combined dosage form. International Journal of Recent Research. 1(1); 2009: 22-26.

  • Indian Pharmacopoeia. Vol. II. The Controller of Publication. 6th ed. Govt. of India. New Delhi, 2010, p. 1199-1201.

  • British Pharmacopoeia. Vol. I. Stationary office. London Medicines and Healthcare product regulatory agency. 2010, p. 672-673, 2606-2610.

  • U. S. Pharmcopoeia/ NF 25 Vol. II, The United state pharmacopeial convention, Twinbrook pathway Rockvillae. 2009, p. 2124-2126.

  • Khaskheli AR, Abro K, Sherazi ST. Simpler and Faster Spectrophotometric Determination of Diclofenac Sodium in Tablet, Serum and Urine samples. Pakistan Jouranl of Analytical and Environmental Chemistry. 10; 2009: 53-58.

  • Nagodi K, Kumar M, Rao M. Spectrophotometric method for Simultaneous estimation of Diclofenac and Nimesulide from combined dosage form. Indian Journal Pharmaceutical Science. 2; 2003: 404-406.

  • El-Sayed YM, Abdel-Hameed ME, Suleiman MS. A Rapid and sensitive HPLC method for the Determination of Diclofenac Sodium in Serum. Journal of Pharmaceutical Science. 40; 2011: 757-729.

  • Gowramma B, Rajan S, Muralidharan S. Validated HPLC method for Simultaneous Estimation of Paracetamol and Diclofenac in Pharmaceutical formulation. International Journal of Chemistry and Technology Research. 2; 2010: 676- 680.

  • Dhaneshwar S, Bhusari V. Validated HPLC method for Simultaneous Quantitation of Diclofenac Sodium and Misoprostol in Bulk drug and formulation. Pelagia Research Library. 1; 2010: 110-118.

  • The International Conference on Harmonization, Q2 (R1), Validation of Analytical Procedure, Text and Methodology, 2005.


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  • Development and Validation of RP-HPLC Method for Simultaneous Estimation of Tramadol Hydrochloride and Diclofenac Sodium in Synthetic Mixture

Abstract Views: 1053  |  PDF Views: 3

Authors

Satish A. Patel
Department of Pharmaceutical Analysis, Centre for Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India
Nilesh B. Chaudhari
Department of Pharmaceutical Analysis, Centre for Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India
Pruthviraj K. Chaudhari
Department of Pharmaceutical Analysis, Centre for Health Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India

Abstract


A simple, accurate, and rapid reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Tramadol Hydrochloride (TRM) and Diclofenac sodium (DIC) in synthetic mixture. The separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH, 6.0) (68:32, v/v). The column used was Phenomenex C18, (250 mm x 4.6 mm i.d., 5 μm) with flow rate 1.2 ml/min using PDA detection at 219 nm. The method was linear over a concentration range 2 - 30 μg/ml for both drugs. The retention time of Tramadol hydrochloride and Diclofenac sodium were found to be 6.30 min and 8.35 min respectively. Results of analysis were validated statistically and by recovery studies. The mean recovery was 99.29 ± 0.54 and 99.03 ± 0.45 for TRM and DIC respectively. The limit of detection (LOD) and the limit of quantification (LOQ) for TRM and DIC were found to be 0.6586 and 1.9956 µg/ml and 0.6169 and 1.8695 μg/ml, respectively. The results of the study showed that the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and also useful for the routine determination of TRM and DIC in mixture.

Keywords


Tramadol Hydrochloride, Diclofenac Sodium, RP-HPLC, Validation

References