Stability Indicating HPLC Method for the Determination of Delamanid in Pharmaceutical Dosage Form

  • Advaita B. Patel Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India
  • Deepa R. Patel Professor, Kalol Institute of Pharmacy, Gandhinagar, Gujarat, India
  • Dhaval M. Patel Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India
  • Mansi Babaria Student, Kalol Institute of Pharmacy, Gandhinagar, Gujarat, India

Abstract

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

Keywords: Delamanid, stability indicating analytical method, HPLC

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Author Biographies

Advaita B. Patel, Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Deepa R. Patel, Professor, Kalol Institute of Pharmacy, Gandhinagar, Gujarat, India

Professor, Kalol Institute of Pharmacy, Gandhinagar, Gujarat, India

Dhaval M. Patel, Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Mansi Babaria, Student, Kalol Institute of Pharmacy, Gandhinagar, Gujarat, India

Student, Kalol Institute of Pharmacy, Gandhinagar, Gujarat, India

References

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6) ICH Harmonized Tripartite Guideline, ICH Q2 (R1); Text & Methodology; November 2007, pp 6
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Patel AB, Patel DR, Patel DM, Babaria M. Stability Indicating HPLC Method for the Determination of Delamanid in Pharmaceutical Dosage Form. JDDT [Internet]. 26Feb.2021 [cited 18Apr.2021];11(1-s):108-12. Available from: http://www.jddtonline.info/index.php/jddt/article/view/4566