Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 5 Issue 1

Simultaneous Estimation of Diclofenac Sodium and Tramadol Hydrochloride Using First Derivative Spectroscopy and RP-HPLC Method

Arup Mondal1, Priyanka Chandra1, Manik Ghosh1, Miral V Naik2, Pankaj Dagur1, Suddhasattya Dey3*, Mithun Bhowmick3, Alindam Ghosh4 and Naresh Kumar Rangra5

1Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, India
2Sigma Institute of Pharmacy, Bakrol, Vadodara, Gujrat, India
3Bengal College of Pharmaceutical Sciences and Research, Durgapur, West Bengal, India
4Sahayog College of Medical Sciences, Khunti, Jharkhand, India
5Department of Pharmaceutical Sciences, Faculty of Medical Science and Health Gurukula Kangri (Deemed to be University), Haridwar, Uttarakhand, India

*Corresponding Author: Suddhasattya Dey, Bengal College of Pharmaceutical Sciences and Research, Durgapur, West Bengal, India.

Received: December 01, 2020; Published: December 22, 2020

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Abstract

  A rapid, sensitive and simple first order derivative and RP-HPLC methods were developed and validated for simultaneous estimation of diclofenac sodium (DIS) and tramadol hydrochloride (THCL) in bulk and their synthetic mixtures. First derivative UV spectrophotometric method has been developed based on the measurement of the absorbance at two wavelengths i.e. 248.6nm for DIS and 293.2nm for THCL linearity of the calibration curve was obtained in the concentration range of 9-45 µg/ml. for DIS and 6-30 µg/ml. for THCL. In bulk as well as in synthetic mixture, the adequate separation of DIS and THCL was observed through RP-HPLC method. Optimum separation was done using Phenomenexluna ODS C18 (150mm X 4.6 mm i.d., 5μm; particle size) with mobile phase consist of acetonitrile, methanol and phosphate buffer (pH 3) in the ratio of 30:30:40 v/v were used at a flow rate of 1.0 ml/min. Injection volume was 20μl and wavelength set at 274 nm. The retention times were found to be 5.78 min and 1.764 min, for DIS and THCL respectively. Linearity of the developed method was found in the range of 15-90μg/ml and 10-60μg/ml for DIS and THCL respectively. The regression coefficient was 0.999 for both DIS and THCL. These two methods were validated according to the ICH guidelines with suitable level of satisfactory for all the parameters. These two methods were found to be simple, fast, and specific for the determination of DIS and THCL in lab as well as industry purpose.

Keywords: Diclofenac Sodium; Tramadol Hydrochloride; First Order Derivative Method; RP-HPLC; Validation

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References

  1. https://www.drugbank.ca/drugs/DB00586
  2. https://www.drugs.com/diclofenac.html
  3. Peraman Ramalingam., et al. "Stability-indicating RP-HPLC-DAD method for the simultaneous estimation of Tramadol HCl and Diclofenac sodium”. Journal of Applied Pharmaceutical Science09 (2017): 085-093.
  4. https://www.drugbank.ca/drugs/DB00193
  5. Dobhi Batuk., et al. "HPTLC method for estimation of dronedarone hydrochloride in both bulk drug and pharmaceutical dosage form”. International Journal of Pharmaceutical Sciences Review and Research 1 (2012): 48-51.
  6. Gunji Revathi., et al. "Simultaneous UV-spectrophotometric determination and validation of diclofenac sodium and rabeprazole sodium using hydrotropic agents in its tablet dosage form”. International Journal of Drug Development and Research 1 (2012): 316-324.
  7. Rachmale PM., et al. “Development and Validation of UV-Spectrophotometric Methods for Simultaneous Determination of Ibuprofen and Tramadol in its Pure and Pharmaceutical Dosage Forms”. Der Pharmacia Lettre9 (2013): 401-405.
  8. Vasava Daxa L., et al. “Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Tramadol Hydrochloride and Diclfenac Sodium in Bulk and Synthetic Mixture”. Journal of Chemical and Pharmaceutical Research5 (2013): 213-218.
  9. El-Bagary R., et al. "Simultaneous spectrophotometric determination of diclofenac sodium, paracetamol, and chlorzoxazone in ternary mixture using chemometric and artificial neural networks techniques”. Asian Journal of Pharmaceutical and Clinical Research 11 (2017): 225-230.
  10. Tunç Sibel., et al. "Spectroscopic investigations of the interactions of tramadol hydrochloride and 5-azacytidine drugs with human serum albumin and human hemoglobin proteins”. Journal of Photochemistry and Photobiology B: Biology 120 (2013): 59-65.
  11. Rekha Kharat. "Estimation of tramadol hydrochloride in bulk and formulation by second order derivative area under curve UV-Spectrophotometric methods”. International Journal of Advances in Scientific Research.
  12. Patel A., et al. "Development and validation of UV spectroscopic method for simultaneous estimation of Methocarbamol and Diclofenac sodium in injection dosage form”. World Journal of Pharmacy and Pharmaceutical Sciences 4 (2016): 1625-1636.
  13. Amin N M., et al. "Development and validation of stability indicating assay method for lornoxicam and tramadol in tablet dosage form by RP-HPLC”. Pharma Science Monitor2 (2012).
  14. Kamble Rajesh M and Shrawan G Singh. "Stability-indicating RP-HPLC method for analysis of paracetamol and tramadol in a pharmaceutical dosage form”. Journal of Chemistry3 (2012): 1347-1356.
  15. Karunakaran K., et al. "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 Research1 (2012): 99-106.
  16. Nasir Fazli., et al. "Simultaneous determination of timolol maleate, rosuvastatin calcium and diclofenac sodium in pharmaceuticals and physiological fluids using HPLC-UV”. Journal of Chromatography B30 (2011): 3434-3443.
  17. Mayee R., et al. "Development and Validation of HPLC Method for Determination of Diclofenac Sodium by Tape Stripping Method”. Asian Journal of Pharmaceutical and Biological Research (AJPBR)3 (2011).
  18. Lindstrom William., et al. "Using AutoDock for virtual screening”. La Jolla (2008).
  19. http://www.rcsb.org/pdb
  20. http://davapc1.bioch.dundee.ac.uk/prodrg/index.html
  21. Bhatt KK., et al. "Development of a validated stability-indicating RP-HPLC method for dronedarone hydrochloride in pharmaceutical formulation”. Journal of Analytical and Bioanalytical Techniques1 (2013): 1-6.
  22. Rao M Madhava., et al. "Development and validation of rp-hplc method for the assay of tramadol hcl in its capsule formulation”. International Journal of Advances in Pharmaceutical Research (2014).
  23. ICH Expert Working Group. "Validation of analytical procedures: text and methodology Q2 (R1)”. Proceedings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland (2005).
  24. Raja M Alagar., et al. "Analytical method development and validation of acetaminophen, dextromethorphan hydro bromide doxylamine succinate in soft gel capsule dosage form by using RP-HPLC”. World Journal of Pharmacy and Pharmaceutical Sciences6 (2013): 5852-5862.
  25. Chaholotiya U K., et al. "TLC method for simultaneous quantification of chlorzoxazone, paracetamol, famotidine and diclofenac potassium in their combined dosage form”. Austin Chromatography1 (2017): 1044.
  26. Bhavsar AS., et al. "Development and validation of Q-absorbance ratio for simultaneous estimation of phenylephrine HCL and Bromhexine HCL in Pharmaceutical dosage form”. Austin International Journal of Recent Scientific Research 1 (2015): 6740-6744.
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Citation

Citation: Suddhasattya Dey., et al. “Simultaneous Estimation of Diclofenac Sodium and Tramadol Hydrochloride Using First Derivative Spectroscopy and RP-HPLC Method". Acta Scientific Pharmaceutical Sciences 5.1 (2021): 83-93.




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