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

PULAGURTHA BHASKARARAO; MATTA SARIKA; CHITRA LAKSHMI MADHAVI; MOHAN GUPTA KOLLIPARA; GUNTUR PRASHANTHI

doi:10.22159/ijcr.2024v8i4.235

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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