Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development and Validation of Stability Indicating Rp-hplc Method for Quantitative Estimation of Ornidazole and Its Impurities in Ornidazole Injection


Affiliations
1 Department of Chemistry, V.S.R Government Degree and P.G. College, Movva, Andhra Pradesh, India
2 Department of chemistry, Acharya Nagarjuna university, Nagarjuna Nagar, Guntur, Andra pradesh, India
     

   Subscribe/Renew Journal


The analysis of improved RP-HPLC method for the separation and quantification of Ornidazole and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Symmetry shield RP18, 250 x 4.6 mm, 5μm, and the mobile phase consists of phosphate buffer: methanol in the ratio of 70:30 %v/v. The flow rate is 1.0 ml/min. The column temperature was maintained at 25°C and sample temperature was maintained at ambient (25°C) and wavelength fixed at 318nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Ornidazole impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, accuracy, solution stability and robustness. Validation study compared as per ICH guideline.

Keywords

Ornidazole injection, Estimation of related substances, Liquid chromatography, Validation.
Subscription Login to verify subscription
User
Notifications
Font Size


  • http://www.genericpedia.com/generic/ornidazole/.

  • http://www.drugs.com/international/ornidazole.html.

  • https://en.wikipedia.org/wiki/Ornidazole.

  • Boeckh M, Lode H, Deppermann KM, Greisen S, Shokry F, Held R. Antimicrob Agents Chemother 1990;34:2407-14.

  • http://www.medsafe.govt.nz/consumers/cmi/a/arrowornidazole.pdf.html.

  • http://www.healthplus24.com/drugs/ornidazole.aspx.html.

  • Mazumder R, Nath LK, Giri TK, Choudhuri PK, Kar AK, Sarkar MK. Int J Pharm Tech Res 2011;3:153-6.

  • Mubeen G, Prakash V, Somashekar PL, Kadri U. Int J Pharm Chem Res 2009;1:318-21. 9. Gandhi VM, Nair SB, Menezes SB, Narayan R.. Int J Res Pharm Chem 2013;3:6-11.

  • Kaur S, Kaur L. J Pharm Innovation 2014;3:1-4.

  • Krishna JR, Sandhya BN, Huidrom S, Prasad VVLN.J Adv Pharm Edu Res 2014;4:405-8.

  • Natraj KS, Suvarna Y, Prasanti G, Saikumar SV. Int Res J Pharm 2013;4:178-81.

  • Dhandapani B, Thirumoorthy N, Rasheed SH, Kotaiah MR, Anjaneyalu N.. Int J Pharm Sci Res 2010;1:78-83.

  • Maheshwari RK, Srivastav VK, Prajapat RP, Jain A, Kamaria P, Sahu S. Int J Pharm Sci 2010;72:258-61.

  • Akhtar J, Shrivastava B, Bhatt P, Patel A, Thakur V. Asian J Pharm Life Sci 2011;1:71-5.

  • Patel SA, Patel NM, Patel MM. Int J Pharm Sci 2006;68:665-7.

  • Nalini CN, Ramachandran S, Kavitha K, Harikrishna. Res J Pharm Biol Chem Sci 2011;2:693-708.

  • Puranik M, Bhaswar DV, Rathi P, Yeole PG. Int J Pharm Sci 2010;72:513-7.

  • Chepurwar SB, Shirkhedkar AA, Bari SB, Fursule RA, Surana SJ. J Chromatogr Sci 2007;45:531-6.

  • ICH guidelines, Validation of Analytical Procedures: Text and Methodology, Q2A (R1) Nov; 2005.


Abstract Views: 148

PDF Views: 0




  • Development and Validation of Stability Indicating Rp-hplc Method for Quantitative Estimation of Ornidazole and Its Impurities in Ornidazole Injection

Abstract Views: 148  |  PDF Views: 0

Authors

N. Prasad Babu
Department of Chemistry, V.S.R Government Degree and P.G. College, Movva, Andhra Pradesh, India
D. Ramachandran
Department of chemistry, Acharya Nagarjuna university, Nagarjuna Nagar, Guntur, Andra pradesh, India

Abstract


The analysis of improved RP-HPLC method for the separation and quantification of Ornidazole and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Symmetry shield RP18, 250 x 4.6 mm, 5μm, and the mobile phase consists of phosphate buffer: methanol in the ratio of 70:30 %v/v. The flow rate is 1.0 ml/min. The column temperature was maintained at 25°C and sample temperature was maintained at ambient (25°C) and wavelength fixed at 318nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Ornidazole impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, accuracy, solution stability and robustness. Validation study compared as per ICH guideline.

Keywords


Ornidazole injection, Estimation of related substances, Liquid chromatography, Validation.

References