, Volume 66, Issue 3–4, pp 247–250 | Cite as

A Validated Stability Indicating RPLC Method for Tazarotene

  • D. B. Pathare
  • A. S. Jadhav
  • M. S. Shingare
Full Short Communication


A simple, isocratic, rapid and accurate reversed phase high performance liquid chromatography method was developed for the quantitative determination of tazarotene. The developed method is also applicable for the related substance determination in bulk drugs. The chromatographic separation was achieved on a Hypersil C18 (250 mm × 4.6 mm 5 μm) column using water pH 2.5 with orthophosphoric acid:acetonitrile (15:85, v/v) as a mobile phase. The chromatographic resolutions between tazarotene and its potential impurity A and B were found greater than three. The limit of detection and limit of quantification of impurities were found to be 25 and 75 ng mL−1. The percentage recovery of impurities in bulk drug sample was ranged from 96.8 to 103.5.The percentage recovery of tazarotene in bulk drug sample was ranged from 98.4 to 100.9. The developed RPLC method was validated with respect to linearity, accuracy, precision and robustness.


Column liquid chromatography Solution and mobile phase stability Forced degradation and validation Tazarotene 



We would like to thank management of Veritec Pharma Ltd, Hyderabad, India for donation of drugs.


  1. 1.
    Tang-Liu DS, Matsumoto RM, Usansky JI (2001) Clin Pharmacokinet 37:273CrossRefGoogle Scholar
  2. 2.
    Chandraratna RA (1996) Br J Dermatol 135(49):18Google Scholar
  3. 3.
    Slialita AR, Chalker DK, Maloney JM, Miller BH, Tachen EH, Chandraratna RA, Gibson JR, Lew-Kaya DA, Lue JC, Sefton J (1999) Cutis 63(6):349Google Scholar
  4. 4.
    Attar M, Yu D, Ni J; Yu Z, Ling KH, Tang-Liu DD (2005) J Pharm Sci 94(10):2246CrossRefGoogle Scholar
  5. 5.
    Draft International Harmonisation of Pharmacopoeias (1993) Text on validation of analytical procedures. Pharmaeuropea 5(4):341Google Scholar
  6. 6.
    ICH, Text on validation of analytical procedures, Q2AGoogle Scholar

Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2007

Authors and Affiliations

  • D. B. Pathare
    • 1
  • A. S. Jadhav
    • 1
  • M. S. Shingare
    • 1
  1. 1.Department of ChemistryDr. B. A. Marathawada UniversityAurangabadIndia

Personalised recommendations