Analytical method development and validation of plerixafor in its dosage form in the presence of tetra-aza-cyclotetra decane derivatives by HPLC

Authors

  • Tasneem Fatima Sultan -Ul-Uloom college of Pharmacy, Banjara Hills, Road No.3, Hyderabad-500 034, Telangana, India.
  • Imam Pasha.S Sultan -Ul-Uloom college of Pharmacy, Banjara Hills, Road No.3, Hyderabad-500 034, Telangana, India.
  • Murali BalaramVaranasi Sultan -Ul-Uloom college of Pharmacy, Banjara Hills, Road No.3, Hyderabad-500 034, Telangana, India.
  • Anupama Koneru Sultan -Ul-Uloom college of Pharmacy, Banjara Hills, Road No.3, Hyderabad-500 034, Telangana, India.
  • M.Mushraff Ali Khan Sultan -Ul-Uloom college of Pharmacy, Banjara Hills, Road No.3, Hyderabad-500 034, Telangana, India.

DOI:

https://doi.org/10.61096/ijpar.v7.iss4.2018.543-557

Keywords:

Plerixafor, HPLC method, Quantification, Formulation, Related substances

Abstract

A  simple  and  selective  HPLC  method  is  described  for  the  determination  of  plerixafor  Chromatographic separation was achieved on a Zorbax eclipse C 18  250x4.6mmx5 micron using mobile phase consisting Water: Methanol: Acetonitrile in the ratio 40:35:25v/v with detection wavelength of 221 nm. Linearity was observed in the range 50-125 µg /ml For Plerixafor (r2 =0.9964) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed method is fully validated with parameters like accuracy,  precision,  linearity,  limit  of  detection,  limit  of  quant ification,  robustness  and  ruggedness.  The proposed method is stability indicating with parameters like acid base peroxide, photolytic and thermal degradation.  No  interference found  from  all  three  impurities of  Plerixafor  that  is  tetraazacyclotetradecane derivatives.

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Published

2022-09-13

How to Cite

Tasneem Fatima, Imam Pasha.S, Murali BalaramVaranasi, Anupama Koneru, & M.Mushraff Ali Khan. (2022). Analytical method development and validation of plerixafor in its dosage form in the presence of tetra-aza-cyclotetra decane derivatives by HPLC. IJPAR JOURNAL, 7(4), 543–557. https://doi.org/10.61096/ijpar.v7.iss4.2018.543-557