QbD-Driven Development and Validation of a Bioanalytical LC–MS Method for Quantification of Paliperidone in Human Plasma
Journal Title: International Journal of Experimental Research and Review - Year 2023, Vol 36, Issue 7
Abstract
This paper discusses how a Quality by Design (QbD) strategy was used to develop and test an HPLC-MS bioanalytical method for detecting plasma Paliperidone concentration. A C18 column and an isocratic mobile phase of organic solvents and water were improved for chromatographic separation. To optimise method performance, Box-Behnken design was used to study column temperature, mobile phase composition, and flow rate. The research used a logical QbD methodology to build an optimised HPLC-MS technology that meets US-FDA standards. Validation studies evaluated selectivity, sensitivity, carryover effects, matrix factor determination, linearity, accuracy and precision testing, recovery, dilution veracity, ruggedness, stability, and reinjection reproducibility, with supporting documentation. The validation studies showed the method's suitability and met acceptance requirements. The QbD framework was successfully used to build and validate an HPLC-MS bioanalytical technique for Paliperidone measurement in human plasma. This method improves chromatographic performance and Paliperidone quantification in clinical and pharmacokinetic studies.
Authors and Affiliations
Jagirdar Sikandar Zoolquernain Farooq, Furquan Nazimuddin Khan
Keywords
Related Articles
- EP ID EP726750
- DOI 10.52756/ijerr.2023.v36.004
- Views 39
- Downloads 0
Enhancing Capsicum Cultivation under Polyhouse, Shadenet House and Open Field Conditions with Drip Fertigation
Capsicum cultivation is a highly challenging task in open field conditions because of the extreme climatic conditions and poor input delivery system. Hence, the protected cultivation of capsicum is catching up. The prese...
Management of essential hypertension through Basti Karma: A case study
Stroke, myocardial infarction, vascular disease, and chronic renal disease are some of the most severe complications that can arise from hypertension. High blood pressure is defined as a systolic reading of 140 mm Hg or...
Pesticide Residue in Marketable Meat and Fish of Nadia district, West Bengal, India
Pesticides are the group of chemicals that used for protection of agricultural and food products by controlling plant and animal pests. The pesticides have significant contribution to increase the yields of agricultural...
Nutritional status and effect of physical activity on anthropmetric characteristics of Bengalee Muslim adolescents boys of North 24 Parganas, West Bengal, India
A cross-sectional study of 522 Bengalee Muslim boys aged 10-17 years of Deganga, North 24 Parganas, West Bengal, India, was undertaken to study their age differences in nutritional status and effect of physical activity...
First record of tail bifurcation in Tokey Gecko (Gekko gecko) from the Kaziranga, Assam, India : a field observation
The Tokay Gecko (Gekko gecko) is the second largest surviving Gecko species and are distributed across much of South-East Asia, Southern China and Northeastern India and Nepal. In Kaziranga landscape Tokay Gecko are fair...