Article Details

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR QUANTITATION OF CLOFARABINE

Asif Shirmana *, Gulam J. Khana , Yaasir A. Ansarib, Shoeb Qazia , Z.E. Inamdarb, Hifjurrahman Siddiqib, Umar F. Syedc , Tasqeeruddin Syedd and Shaheen Syedae

a Department of Quality Assurance, Ali Allana College of Pharmacy, Akkalkuwa, Nandurbar-425 415, Maharashtra, India

b Department of Quality Assurance, Jamia college of Pharmacy, Akkalkuwa, Nandurbar-425 415, Maharashtra, India

c Department of Pharmaceutics, Care College of Pharmacy, Warangal Rural, Oglapur - 506 006, Telangana, India

d Department of Pharmaceutical Chemistry, College of Pharmacy, King Khalid University, Abha-61421, Saudi Arabia

e Department of Pharmacology, Anwarul Uloom College of Pharmacy, Mallepally, Hyderabad-500 001, Telangana, India

* For Correspondence: E-mail: amshirman@gmail.com

 

https://doi.org/10.53879/id.59.01.12445.


ABSTRACT

This experiment aims to develop and validate the RP-HPLC method for clofarabine in a bulk and pharmaceutical dosage form. Chromatographic separation was achieved on Inertsil ODS 3V (150× 4.6 mn) diameter column. The mobile phase comprised of phosphate buffer (pH 4.0): methanol (40:60) at a flow rate of 1 mL min-1 and all eluents were detected at 270 nm. The runtime was 10 minutes. Calibration curves at five levels for clofarabine were linear in the range of 10-30 µg mL-1. Accuracy for clofarabine was studied in the range of 50-150 % quality control standard levels. A validated method was found to be accurate, reproducible, linear, precise, and robust.

Year 2022 | Volume No. 59 | Issue No.1 | Page No. 60-63
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