BIO ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF CAPECITABINE AND DOCETAXEL AND ITS APPLICATION TO PHARMACOKINETIC STUDIES USING LC-MS/MS

SHAIK NAGUL SHAREEF; K. V. PADMAVATHI; S. ARAVIND; MANNAM SUBBARAO

doi:10.22159/ijap.2024v16i4.50125

Authors

SHAIK NAGUL SHAREEF Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, A. P, India https://orcid.org/0000-0001-7962-4710
K. V. PADMAVATHI Department of Chemistry, T. R. R. Govt. Degree College, Kandukur, SPSR Nellore District, India
S. ARAVIND Department of Chemistry, University College of Science, Saifabad, Osmania University, Hyderabad-500004, Telangana State, India
MANNAM SUBBARAO Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, A. P, India

DOI:

https://doi.org/10.22159/ijap.2024v16i4.50125

Keywords:

Capecitabine, Docetaxel, LC-MS/MS, USFDA guidelines

Abstract

Objective: An easy, quick, precise, active and reproducible Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) technique was developed for the bio-analytical method of Capecitabine and Docetaxel using D₉-Capecitabine and D₉-Docetaxel as Internal Standards (IS).

Methods: This article summarizes the recent progress on bioanalytical LC-MS/MS methods using Symmetry C₁₈ column (150x4.6 mm, 3.5µ) and an organic mobile phase of 0.1% formic acid and Acetonitrile in 80:20 v/v.

Results: Analysis was carried out within 5 min over a good linear concentration range from 37.5ng/ml to 300ng/ml (r²= 0.9999±0.008) for Capecitabine and 10ng/ml to 80ng/ml (r²=0.9993±0.005) for Docetaxel. Accuracy, precision, recovery, matrix effect and stability results were found to be within suitable limits.

Conclusion: The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with United States Food and Drug Administration (USFDA) guidelines and applied effectively for the investigation of pharmacokinetic studies in rats.

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