High performance liquid chromatography of drugs is usually performed with the help of organic mobile phase like Methanol, Acetonitrile etc., which are toxic, volatile and expensive. In the present study, an Ecofriendly cost-effective hydrotropic solution (5% Urea in HPLC grade water) was employed as mobile phase for the estimation of poorly aqueous soluble drugs Paracetamol and Diclofenac sodium by RP-HPLC. The analysis was carried out on Shimadzu LC6AD dual pump with PDA Detector SPD-M20A, and Rheodyne injector (20µL loop). The analytical column used was Shimadzu shim packC18 column with 5µm particle size and dimension of 4.6×250mm. Urea solution (5%) at a flow rate of 1.0mL/minute was employed as mobile phase and the drugs were detected at 268nm at ambient temperature. Novel ecofriendly mobile phase, comprising of 5% Urea solution was found to be satisfactory and give sharp peaks for Paracetamol and Diclofenac sodium with retention time 3.272 and 1.772 min respectively. The method was validated as per ICH guidelines. Linearity for detector response was observed in 100- 500µg/mL for Paracetamol and 10- 50µg/mL for Diclofenac sodium. Percentage recovery for Paracetamol and Diclofenac sodium were 99.97 and 99.79 respectively, indicates accuracy of the proposed method. The %RSD for both tablet analysis and recovery studies were less than 2% indicates high degree of precision. The LOD and LOQ values showed that the proposed method is sensitive. Therefore, the developed method employing hydrotropic solution as mobile phase was novel, simple, precise, cost effective, ecofriendly, safe and can be successfully applied for the routine analysis of Paracetamol and Diclofenac sodium in pharmaceutical dosage forms.
Cite this article:
Remi. S. L, Joyamma Varkey, R. K. Maheshwari, A. Jayakumaran Nair. A Novel Ecofriendly, Cost effective mobile phase for HPLC- Simultaneous estimation and Validation of Paracetamol and Diclofenac sodium in Bulk and Pharmaceutical Formulation by RP-HPLC using Hydrotropic Solution as Mobile phase. Asian J. Pharm. Res. 2020; 10(3):163-170. doi: 10.5958/2231-5691.2020.00029.5
1. Indian Pharmacopoeia. Government of India Vol. II. Ministry of Health and Family Welfare, Indian Pharmacopoeial commission. 2010; pp.1861-1862.
2. Indian Pharmacopoeia. Government of India Vol. II. Ministry of Health and Family Welfare, Indian Pharmacopoeial commission. 2010; pp.1200-1202.
3. Remi S L, Joyamma Varkey, Maheshwari R K. Novel RP-HPLC method development and validation of Cefixime in bulk and their dosage form by using Hydrotropic solution as mobile phase. Asian journal of Pharmaceutical and Health Sciences. 2018; 8(2):1907-1914.
4. Nagwa H S, Ahmida, Mariam S Abu. Determination of Paracetamol in Tablet by Difference Spectrophotometric Method. Asian Journal of Chemistry. 2009; 21(3):2233-2240.
5. Oza C K, Nijhawan R, Pandya M K. Dual Wavelength Spectrophotometric method for the simultaneous determination of Paracetamol and Nabumetone in API and in tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2012; 2(4): 122-127.
6. Audumbar Mali, Sujata Kolekar, Jeeja Panachery. Simultaneous Determination of Paracetamol and Domperidone in Pharmaceutical Dosage Form by First Order Derivative UV Spectrophotometry. Asian Journal of Pharmaceutical Research. 2016; 6(1): 22-26.
7. Rawat S, Akhilesh Gupta. Spectrophotometric Method for Simultaneous Estimation of Nimesulide and Diclofenac Sodium in Pharmaceutical Dosage Forms. Asian Journal of Pharmaceutical Analysis. 2011; 1(4): 85-87.
8. Vanparia D J, Shah S A, Marolia B P. Spectrophotometric Methods for Simultaneous Estimation of Thiocolchicoside and Diclofenac sodium in Their Combined Dosage Form. Asian Journal of Research in Chemistry.2011; 4(1): 123-127.
9. Derkar Ganesh K, Chimkode R M, Katore Gaurav. Development and validation of UV-Visible Spectrophotometric methods for the estimation of Paracetamol and Diclofenac sodium in bulk and tablet dosage form. International Journal of Pharmaceutical Research and Analysis. 2015; 5(1): 52-57.
10. Sathish Kumar Konidala, Adinarayana Penumala, Vinod Kumar Mugada. Development and validation of RP-HPLC method for simultaneous estimation of Paracetamol and Flupirtine Maleate. Asian Journal of Pharmaceutical Analysis.2015; 5(2): 105-111.
11. Jigar Patel, Pinak Patel. RP-HPLC method development and validation for the estimation of Diclofenac Sodium, Tramadol Hydrochloride and Chlorzoxazone from their combined tablet dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(7): 632-637.
12. Prasanna Reddy Battu, M S Reddy. RP-HPLC Method for Simultaneous Estimation of Paracetamol and Ibuprofen in Tablets. Asian Journal of Research in Chemistry. 2009; 2(1): 70-72.
13. Maniteja K, Purvil Chovatia, Jaya Naimisha. Simultaneous Estimation of Eperisone Hydrochloride and Diclofenac Sodium in Pharmaceutical Dosage Form by RP- HPLC. Asian Journal of Research in Chemistry. 2014; 7(9): 783-786.
14. Gurupadayya B M, Sirisha T, Sridhar S. RP-HPLC-PDA method for the determination of Paracetamol, Famotidine, Diclofenac Potassium and Chlorzoxazone in bulk and marketed formulation. International Journal of Pharmaceutical and Clinical Research 2017; 9(12): 696-701.
15. Gowramma B, Rajan S, Muralidharan S A. Validated RP-HPLC method for simultaneous estimation of Paracetamol and Diclofenac Potassium in pharmaceutical formulation. International Journal of Chem Tech Research. 2010; 2(1): 676-680.
16. Smita J Pawar, Amol P Kale, Manoj P. HPTLC estimation of Paracetamol, Diclofenac sodium and Chlorzoxazone in Tablet dosage form. Asian Journal of Research in Chemistry. 2009; 2(3): 306-309.
17. Mahashwari R K, Chaturvedi S C, Jain N K. Application of Hydrotrophy in Spectrophotometric determination of pharmaceutical dosage forms. Indian Drugs. 2005; 42(11): 760-763.
18. Gurumurthy V, Deveswaran R, Bharath S. Application of Hydrotropic Solubilisation in Simultaneous Estimation of Atenolol and Amlodipine Besylate. Asian Journal of Research in Chemistry. 2012; 5(1): 57-60.
19. Jyothi G, Shravan Kumar D, Bhavani P. Eco-Friendly Spectrophotometric Estimation of Gliclazide using Hydrotropic Solubilization Technique. Asian Journal of Pharmaceutical Analysis. 2019; 9(2):45-48.
20. Akshay Waghmare, Ganesh Taware, Shrikrishna Baokar. Ecofriendly Validated Spectrophotometric Method for the Estimation of Amlodipine Besylate by using Hydrotropic Solubilization Method. Asian Journal of Pharmaceutical Analysis. 2019; 9(1): 08-10.
21. Usha Rani N, Keerthana K, Mitha M. New Spectroscopic Method for Estimation of Atorvastatin Tablets Using Hydrotropic Solubilization Technique. Asian Journal of Pharmaceutical Analysis. 2015; 5(2): 100-104.
22. Jyoti Dahiya, Anuradha Singh, Shiv Kumar Gupta. Spectrophotometric Estimation of Dextromethorphan in Bulk Drug using Hydrotropic Solubilization Technique. Asian Journal of Pharmaceutical Analysis. 2013; 3(3): 90-93.
23. Jayronia Sonali, Yadav Kamaldeep. Hydrotropy- A novel approach in estimation of poorly aqueous soluble drugs by TLC. International Journal of Pharmacy and Pharmaceutical Sciences. 2013;5(2): 176-178.
24. Salunke P A, Barhate S D, Chavhan B R. Separation of Dyes by Mixed Hydrotropic Thin Layer Chromatography. Asian Journal of Pharmaceutical Analysis. 2019; 9(3): 151-155.
25. Pareek V, Tambe S R, Bhalerao S B. Role of different hydrotropic agents in Spectrophotometric and Chromatographic estimation of Cefixime. International Journal of Pharma and Bio Sciences. 2010;1(3): 1-9.
26. Deepak Ghogare, Sheetal Patil. Hydrotropic Solubilisation: Tool for eco-friendly analysis. International Journal of Pharmacy and Pharmaceutical Research. 2018; 11(3): 300-322.
27. ICH. Q2A Validation of analytical procedure- Guidelines, Methodology, International Conference on Harmonization. Steering Committee, Geneva. 1994: 6-13.