BIO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FLUPENTIXOL AND NORTRIPTYLINE HCL IN RAT PLASMA AND ITS PHARMACOKINETIC STUDIES BY LCMS

V. VISALAKSHAMMA; B. SRI RAMUDU; SYED. KHASIM SHARIF; P. BHARATH; D. RAMACHANDRAN; P. T. S. R. K. PRASADA RAO; K. PRASADA RAO

doi:10.22159/ijap.2025v17i1.52653

Authors

V. VISALAKSHAMMA Department of Chemistry, University College of Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, Andhra Pradesh-522510, India
B. SRI RAMUDU Department of Chemistry, Adikavi Nannaya University Campus, Tadepalligudem, Andhra Pradesh-534101, India
SYED. KHASIM SHARIF Department of Chemistry, Dr SRK Govt. Arts College, Yanam, Affiliated to Pondicherry Central University, Andhra Pradesh-533464, India
P. BHARATH Department of Chemistry, University College of Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, Andhra Pradesh-522510, India
D. RAMACHANDRAN Department of Chemistry, University College of Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, Andhra Pradesh-522510, India
P. T. S. R. K. PRASADA RAO Department of Chemistry, P B Siddhartha College of Arts and Science, Vijayawada, Andhra Pradesh-520010, India
K. PRASADA RAO Department of Chemistry, P B Siddhartha College of Arts and Science, Vijayawada, Andhra Pradesh-520010, India

DOI:

https://doi.org/10.22159/ijap.2025v17i1.52653

Keywords:

Flupentixol, Nortriptyline HCl, LC-MS/MS, USFDA guidelines, Rat plasma

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 flupentixol and nortriptyline HCl using zuclopenthixol as Internal Standard (IS).

Methods: This article summarizes the recent progress on bio-analytical LC-MS/MS methods using Luna Phenyl Hexyl column (250x4.6 mm, 5µ) and organic mobile phase of Ammonium acetate pH-3.0/Formic acid and Acetonitrile in 70:30 v/v. 5 min of run time was used in the analysis.

Results: The calibration curve was linear in the range of 5.0ng/ml to 200.0ng/ml (r²= 0.99988±0.006) for nortriptyline HCl and 0.25ng/ml to 10.0ng/ml (r²=0.99972±0.007) for flupentixol. Matrix effect, recovery and stability results were within the acceptable limit. An electrospray ionization source was used to study of nortriptyline HCl, flupentixol at m/z 300.8471 →73.2501, m/z 435.5225→103.4247 and m/z 400.9657→142.0087 for zuclopenthixol were ion pairs of mass analysis.

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 rat.

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