Development & validation of a simple, sensitive, robust, reproducible & economical spectrofluorimetric method for estimation of taurine in novel chewable gel
Year: 2024
Type: article
Abstract: Background: Taurine, known as 2-aminoethanesulphonic acid, is a sulfur-containing β-amino acid not incorporated into proteins. However, it takes part in biochemical reactions of significant importance, such as conjugation with bile acids to form bile salts essential for fat absorption, cell membrane stabilization, antioxidation, detoxification, osmoregulation, neuromodulation, and brain and retinal development. Objective: To increase its dissolution and absorption rate for early onset of action, we developed a medicated gel formulation of taurine. Chewable gels are suitable dosage forms for pediatric, geriatric, and dysphagic patients. The current research aims to develop a simple, sensitive, and reproducible spectrofluorometric method for determining taurine in chewable gel. Method: A spectrofluorimetric method was developed, and the determination of taurine was based on Hantzsch condensation synthesis, and the fluorescence intensity was measured at emission wavelength (λem) of 474 nm after excitation (λex) at 416 nm. The spectrofluorimetry method for taurine was validated according to the Q2B(R1) ICH guideline for method validation and validated for linearity, LOD, LOQ, interday and intraday precision, accuracy, and robustness. Results: The calibration curve was linear in a 1.5-50 µg/ml concentration range. The correlation coefficient (r2) was found to be 0.994. The % RSD values of intra-day precision lie between 0.11 and 0.09; for inter-day precision, it was found to be between 0.09 and 0.11; in both cases, it is less than 2 %. The percentage accuracy study was between 91.81 and 99.93 with a % RSD value of 0.078, less than 2 %. LOD & LOQ values have been mathematically calculated to 4.03 µg/ml and 12.23 µg/ml, respectively. The method was precise, accurate, and robust. Conclusion: All validation parameters were found to be within their acceptable limits. Thus, the developed spectrofluorimetric method of taurine is economical, fast, and robust. Further, this method was utilized to estimate taurine content uniformity in chewable gel for in-vitro release studies.
Source: IBRO Neuroscience Reports
Authors: Ranjana Bhandari, Niharika Goswami, Yuvraj Patidar, Pritiman Pothal, Jyoti K. Paliwal, Anurag Kuhad
Institution: Panjab University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
Estimated APC paid: $1,500
Award: G6717760318
OpenAlex ID: W4404801832