ABSTRACT:
A novel eco-friendly, safe and cost-effective RP-HPLC method was developed for the estimation of poorly water-soluble drug Ornidazole. In most of the RP-HPLC analysis toxic, volatile and expensive organic solvents are used as mobile phase. In the present study, an eco-friendly cost -effective hydrotropic solution (5%Urea in HPLC grade water) was employed as solubilizing agent and mobile phase for the estimation of poorly aqueous soluble drug Ornidazole 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 drug was detected at 320 nm at ambient temperature. Novel eco-friendly mobile phase, comprising of 5% Urea solution was found to be satisfactory and give sharp peak for Ornidazole with retention time 3.996min. The method was validated as per ICH guidelines. Linearity was observed over the concentration range 10- 50µg/ml (R2=0.9990) with regression equation y=49321x+33223. Percentage recovery for Ornidazole was 99.36, 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 are 0.015771µg/ml and 0.047793µg/ml respectively, showed that the proposed method is sensitive. The developed method employing hydrotropic solution as mobile phase was novel, simple, precise, cost-effective, eco-friendly, safe and can be successfully applied for the routine analysis of Ornidazole in bulk and pharmaceutical dosage forms.
Cite this article:
Remi. S. L, Joyamma Varkey, A. Jayakumaran Nair, Vishnu. S. Sanjeev. Application of an Eco-friendly, Cost-effective Hydrotropic solution as mobile phase for the estimation and validation of Ornidazole in bulk and Pharmaceutical Formulation by RP-HPLC. Asian J. Res. Pharm. Sci. 2021; 11(1):15-21. doi: 10.5958/2231-5659.2021.00003.5
Cite(Electronic):
Remi. S. L, Joyamma Varkey, A. Jayakumaran Nair, Vishnu. S. Sanjeev. Application of an Eco-friendly, Cost-effective Hydrotropic solution as mobile phase for the estimation and validation of Ornidazole in bulk and Pharmaceutical Formulation by RP-HPLC. Asian J. Res. Pharm. Sci. 2021; 11(1):15-21. doi: 10.5958/2231-5659.2021.00003.5 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2021-11-1-3
1. http://www.genericpedia.com/generic/ornidazole/.
[Last accessed on 10 June 2020].
2. 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.
3. Suntara Fueangfung, Yinan Yuan, Shiyue Fang. Denaturing
Reversed-Phase HPLC using a mobile phase containing Urea for Oligodeoxynucleotide
Analysis. Nucleosides, Nucleotides and Nucleic Acids. 2014; 33: 481–488.
4. Toru Takahashi, Hitishi Hoshino, Takao yotsuyanagi. The
use of water structure breakers, Urea and Guanidium chloride, New mobile phase
modifiers in Reversed-Phase Partition High Performance Liquid Chromatography.
Analytical Sciences. 2001; 17: 847-851
5. Jyotsna Patil, Malathi Raghunath, Shweta Patil.
Analytical Method Development and Validation of Ornidazole in tablet dosage
form by Zero Order UV Spectroscopy. International Journal of Pharmacy and
Pharmaceutical Sciences. 2016; 8(3): 249-254
6. Mubeen G, Vineeta Prakash, Somashekar P L.
Spectrophotometric Method for Determination of Ornidazole. International
Journal of chem Tech Research. 2009; 1(2): 318-321.
7. Tulasamma P, Govind V, Venkateswarlu P.
Spectrophotometric determination of Ornidazole in Pure and Pharmaceutical
Formulations. International Journal of Pharma Sciences and Research. 2011;
2(1): 44-48
8. Jadhav R S, Kendre P N, Kolhe M H. RP- HPLC method for
Simultaneous Estimation of Ofloxacin and Ornidazole from Bulk and Tablets.
Research Journal of Science and Technology. 2009; 1(1): 43-46.
9. Dhandapani B, Thirumoorthy N, Shaik Harun Rasheed.
Method development and validation for the simultaneous estimation of Ofloxacin
and Ornidazole in tablet dosage form by RP-HPLC. International Journal of Pharma Sciences and
Research. 2010; 1(1) :78-83.
10. Veena K, Sireesha D, Rajini T. Analytical method
development and validation for the simultaneous estimation of Cefixime
Trihydrate and Ornidazole in combined dosage form by RP-HPLC Method. Indo
American Journal of Pharmaceutical Research. 2015; 5(10): 3128-3134.
11. Ramya Krishna J, Naga B. Development and validation of
RP-HPLC method for the simultaneous estimation of Ciprofloxacin hydrochloride
and Ornidazole in combined pharmaceutical dosage form. Journal of Advanced
Pharmaceutical Education and Research. 2014; 4 (4):440-443
12. Manisha Puranik, Bhawsar D V, Prachi Rathi.
Simultaneous determination of Ofloxacin and Ornidazole in Solid Dosage Form by
RP-HPLC and HPTLC Techniques. Indian Journal of Pharmaceutical Sciences. 2010;
72 (4): 513-517
13. Gandhimathi
M, Ravi T K, Nilima S. Simultaneous determination of ornidazole and ofloxacin
by High Performance Thin Layer Chromatography. Indian Journal of Pharmaceutical
Sciences. 2006; 68: 838-840.
14.
Chepurwar S B, Shirkhedkar A A, Bari S B. Validated HPTLC method for
simultaneous estimation of Levofloxacin hemihydrate and Ornidazole in
pharmaceutical dosage form. Journal of Chromatographic Science. 2007; 45:
531-536.
15. Maheshwari R K,
Chaturvedi S C, Jain N K. Application of Hydrotropy in Spectrophotometric
determination of pharmaceutical dosage forms. Indian Drugs. 2005; 42(11):
760-763.
16. Visweswara Rao G, Prasanti S, Kiran D S.
Spectrophotometric and HPLC Methods for Poorly Water-Soluble Drug.
International Journal of Pharmacy and Pharmaceutical Research. 2018, 12 (3):
466-474
17. 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.
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. 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.
20.
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.
21. 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
22. 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.
23. Deepak Ghogare, Sheetal Patil. Hydrotropic
Solubilisation: Tool for eco-friendly analysis. International Journal of
Pharmacy and Pharmaceutical Research. 2018; 11(3): 300-322.
24. ICH. Q2A Validation of analytical procedure- Guidelines,
Methodology, International Conference on Harmonization. Steering Committee,
Geneva. 1994: 6-13.