Stability Indicating HPLC Method for the Determination of Delamanid in Pharmaceutical Dosage Form
Delamanid is successfully used for treatment of MDR TB. A stability indicating analytical method has been developed and validated. In this study Delamanid was degraded under different stress test conditions as per International Conference on Harmonization. The degraded samples were used to develop a stability-indicating high performance liquid chromatographic (HPLC) method for the Delamanid. The Delamanid was well separated from degradation products using a reversed-phase Hypersil BDS C18 (250 mm × 4.6mm i.d., 5µm) column and a mobile phase comprising of 0.01M pH 2.70 Phosphate Buffer: Acetonitrile (pH 3.50) 70:30, pH of mobile phase was adjusted with Glacial acetic acid and other HPLC parameters were flow rate 1 mL/min, detection wavelength 254 nm and injection volume 10 µl. The method was validated for linearity, precision, accuracy, ruggedness and robustness. Results obtained after validation study indicating that the proposed single method allowed analysis of Delamanid in the presence of their degradation products formed under a variety of stress conditions. The developed procedure was also applicable to the determination of stability of the Delamanid in commercial pharmaceutical dosage form.
Keywords: Delamanid, stability indicating analytical method, HPLC
2) Walker R., Cate W. Clinical Pharmacy & Therapeutics; 4th ed, Churchill Livingstone Elsevier, United Kingdom, 2008, p 629
3) Snyder LR., Kirkland JL., Glajch JL. Practical HPLC Method Development; 2nd ed, Wiley Interscience, New York, 1997, p 205-227,234,266.
4) Robinson JW., Skelly EM., Frame GM. Undergraduate Instrumental Analysis; 6th ed, Marcel Dekker, New Jersey, 2005, p 6.
5) Patel A. B , “Analytical Method Validation: Collation between International Guidelines, Asian Journal of Research in Chemistry”, 2017; 10(6):1-10.
6) ICH Harmonized Tripartite Guideline, ICH Q2 (R1); Text & Methodology; November 2007, pp 6
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).