Next Article in Journal
Enhanced Bioavailability and Dissolution of Atorvastatin Calcium from Floating Microcapsules using Minimum Additives
Previous Article in Journal
Screening and HPLC-Based Activity Profiling for New Antiprotozoal Leads from European Plants
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2013, 81(4), 1003-1016; doi:10.3797/scipharm.1305-20

Stability-Indicating UPLC Method for Tramadol HCl Impurities in the Tramadol Injection after Dilution by Infusion Fluids (5% Dextrose and 0.9% Sodium Chloride)

1
Pharmaceutical Technology Center, Cadila Healthcare Ltd, Moraiya, Ahmedabad-382210, Gujarat, India
2
Center for Chemical Sciences and Technology, IST, J.N.T. University, Kukatpally, Hyderabad-500072, A. P., India
3
J. N. T. University affiliated research guide, Kukatpally, Hyderabad-500072, A. P., India
*
Author to whom correspondence should be addressed.
Received: 20 May 2013 / Accepted: 14 July 2013 / Published: 14 July 2013
Download PDF [1327 KB, uploaded 29 September 2016]

Abstract

A novel, rapid, and sensitive ultra-performance liquid chromatography (UPLC) method has been developed and validated as per ICH guidelines for the determination of tramadol HCl impurities in the tramadol HCl injection after reconstitution by infusion fluids (5% dextrose and 0.9% sodium chloride). The tramadol HCl injection is for the treatment of patients with moderate-to-severe pain. The stability of the reconstituted solution is critical before intravenous injection. The literature search resulted in few published articles on assays of tramadol in infusion fluids by conventional HPLC. No attempts have yet been made to determine the impurities in infusion fluids, as the concentration of tramadol after reconstitution is extremely low (0.4 mg/mL) and that of impurities is even lower. The proposed method is novel as it allows the quantitation of the impurities of tramadol HCl and is based on modern chromatographic techniques like UPLC. The method was developed using the Waters Acquity BEH C18 column with a mobile phase consisting of a gradient mixture of solvent A (trifluroacetic acid buffer) and solvent B (methanol: acetonitrile). The model stability study was designed by diluting the tramadol HCl injection in the 5% dextrose injection and 0.9% sodium chloride injection. Each mixture was kept under storage at room temperature (25 ± 2°C) for testing at initial, 2, 4, 8, 12, 18 & 24 hours. The validation study illustrates that the proposed method is suitable for the determination of tramadol and its impurities. The proposed method makes use of the LC-MS-compatible mobile phase. It can be useful for the determination of tramadol HCl and its impurities in plasma samples and other pharmaceutical dosage forms.
Keywords: Stability-indicating UPLC method; Tramadol HCl impurities; 5% Dextrose injection; 0.9% Sodium Chloride injection; Validation; Stability study Stability-indicating UPLC method; Tramadol HCl impurities; 5% Dextrose injection; 0.9% Sodium Chloride injection; Validation; Stability study
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

MDPI and ACS Style

BINNOR, A.K.; MUKKANTI, K.; SURYANARAYANA, M.V.; ROY, S.B. Stability-Indicating UPLC Method for Tramadol HCl Impurities in the Tramadol Injection after Dilution by Infusion Fluids (5% Dextrose and 0.9% Sodium Chloride). Sci. Pharm. 2013, 81, 1003-1016.

Show more citation formats Show less citations formats

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Sci. Pharm. EISSN 2218-0532 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top