THE INDUSTRIAL IMPORTANCE OF TECHNOLOGY TRANSFER FOR ANALYTICAL METHOD DEVELOPMENT AND VALIDATION–APPLICATION TO VILAZODONE HYDROCHLORIDE DOSAGE FORM

Authors

  • PULAGURTHA BHASKARARAO Aditya Pharmacy College, Surampalem-533437, Andhra Pradesh, India. Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India https://orcid.org/0000-0001-6676-2655
  • MATTA SARIKA Aditya Pharmacy College, Surampalem-533437, Andhra Pradesh, India. Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India
  • CHITRA LAKSHMI MADHAVI Aditya Pharmacy College, Surampalem-533437, Andhra Pradesh, India. Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India
  • MOHAN GUPTA KOLLIPARA Medrich Limited, M. S. Nagar, Bengaluru, Karnataka, India
  • GUNTUR PRASHANTHI Aditya Pharmacy College, Surampalem-533437, Andhra Pradesh, India. Jawaharlal Nehru Technological University Kakinada, Kakinada, Andhra Pradesh, India https://orcid.org/0009-0004-6366-9091

DOI:

https://doi.org/10.22159/ijcr.2024v8i4.235

Keywords:

Vilazodone HCl, UPLC, ICH, Tech transfer, Validation

Abstract

Objective: The research aims to create a fast, economical, and efficient tech transfer method for analyzing bulk materials and pharmaceutical dosage forms.

Methods: The analysis was performed using an Acquity UPLC BEH C18 analytical column (130 Å, 1.7 µm, 3 mm x 100 mm) with detection of the analyte at 238 nm. The mobile phase flow rate was optimized at 0.3 ml/min, and an injection volume of 0.5 µl** was used. The isocratic mobile phase consisted of a blend of buffer (0.1% OPA) and acetonitrile at a ratio of 40:60% v/v.

Results: All validation parameters of the analytical method were acceptable. The analyte eluted at 3.08 min with satisfactory theoretical plates and a tailing factor. The recovery of the analyte was 99-100%, and the method's precision was 0.59 and 0.72% RSD. The technique showed no interference, indicating specificity. The linearity was demonstrated over the 20-60 µg/ml range, with a regression coefficient of 0.999.

Conclusion: The developed method is cost-effective, specific with minimal interference, and time-saving. It also reduces solvent consumption for quality control analysis of vilazodone hydrochloride samples. The method demonstrates good linearity, robustness, and accuracy.

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Published

01-10-2024

How to Cite

BHASKARARAO, P., M. SARIKA, C. L. MADHAVI, M. G. KOLLIPARA, and G. PRASHANTHI. “THE INDUSTRIAL IMPORTANCE OF TECHNOLOGY TRANSFER FOR ANALYTICAL METHOD DEVELOPMENT AND VALIDATION–APPLICATION TO VILAZODONE HYDROCHLORIDE DOSAGE FORM”. International Journal of Chemistry Research, vol. 8, no. 4, Oct. 2024, pp. 12-17, doi:10.22159/ijcr.2024v8i4.235.

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Research Article
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