Method Development and Process Validation of Glucose Estimation in Chewable Tablets by Rp-Hplc
GLUCOSE ESTIMATION IN CHEWABLE TABLETS BY RP-HPLC
DOI:
https://doi.org/10.60988/p.v36i3.34Keywords:
Chewable tablets, Procees Validation, Method Development, Glucose, RP-HPLCAbstract
Several analytical procedures use the HPLC method to test glucose in other dosage forms, but there isn’t yet for tablet dosage forms. To determine glucose in chewable tablet dosage form using RP-HPLC, we thus concentrate on creating a single efficient approach. This study aims to develop and validate a simple, accurate, rapid, and economical method for glucose chewable tablets by RP-HPLC. The validated method is used to validate the process at each stage of tablet production. Chromatographic runs were carried out on a Bondapak NH2 (10 µm, 3.9 mm x 300 mm) column with a mobile phase of water and acetonitrile (70:30) at a flow rate of 1 mL/min and detected using an RI detector as per ICH guidelines. The method is shown to be linear in the range of 80% (1.6 mg/mL) to 120% (2.4 mg/mL) of operating concentration with a correlation coefficient of 0.999, accurate at a recovery rate of 98.0% and 102.0%, and robust to changes in mobile phase ratio and flow rate. It is a simple, accurate, economical, fast, and precise method for glucose.
References
References:
Sahu, P.K.; Ramisetti, N.R.; Cecchi, T.; Swain, S.; Patro, C.S.; Panda, J. An Overview of Experimental Designs in HPLC Method Development and Validation. J. Pharm. Biomed. Anal., 2018, 147, 590–611.
Almeida, C.M.M. Overview of Sample Preparation and Chromatographic Methods to Analysis Pharmaceutical Active Compounds in Waters Matrices. Separations, 2021, 8, 1–50.
Chapter 4 Reversed Phase Chromatography of Peptides. Tech. Instrum. Anal. Chem., 1984, 6, 51–73.
Gritti, F.; Guiochon, G. Adsorption Mechanism in Reversed-Phase Liquid Chromatography. Effect of the Surface Coverage of a Monomeric C18-Silica Stationary Phase. J. Chromatogr. A, 2006, 1115, 142–163.
De Luca, C.; Buratti, A.; Krauke, Y.; Stephan, S.; Monks, K.; Brighenti, V.; Pellati, F.; Cavazzini, A.; Catani, M.; Felletti, S. Investigating the Effect of Polarity of Stationary and Mobile Phases on Retention of Cannabinoids in Normal Phase Liquid Chromatography. Anal. Bioanal. Chem., 2022, 414, 5385–5395.
Galant, A.L.; Kaufman, R.C.; Wilson, J.D. Glucose: Detection and Analysis. Food Chem., 2015, 188, 149–160.
Musuc, A.M.; Anuta, V.; Atkinson, I.; Sarbu, I.; Popa, V.T.; Munteanu, C.; Mircioiu, C.; Ozon, E.A.; Nitulescu, G.M.; Mitu, M.A. Formulation of Chewable Tablets Containing Carbamazepine-β-Cyclodextrin Inclusion Complex and f-Melt Disintegration Excipient. The Mathematical Modeling of the Release Kinetics of Carbamazepine. Pharmaceutics, 2021, 13, 915.
Sawatdee, S.; Atipairin, A.; Yoon, A.S.; Srichana, T.; Changsan, N.; Suwandecha, T. Formulation Development of Albendazole-Loaded Self-Microemulsifying Chewable Tablets to Enhance Dissolution and Bioavailability. Pharmaceutics, 2019, 11, 134.
Sahu, P.K.; Ramisetti, N.R.; Cecchi, T.; Swain, S.; Patro, C.S.; Panda, J. An Overview of Experimental Designs in HPLC Method Development and Validation. J. Pharm. Biomed. Anal., 2018, 147, 590–611.
Tian, M.; Row, K.H. Separation of Glucose and Bioethanol in Biomass with Current Methods and Sorbents. J. Chromatogr. Sci., 2013, 51, 819–824.
Bortolotti, F.; Sorio, D.; Bertaso, A.; Tagliaro, F. Analytical and Diagnostic Aspects of Carbohydrate Deficient Transferrin (CDT): A Critical Review over Years 2007–2017. J. Pharm. Biomed. Anal., 2018, 147, 2–12.
Duarte-Delgado, D.; Narváez-Cuenca, C.E.; Restrepo-Sánchez, L.P.; Kushalappa, A.; Mosquera-Vásquez, T. Development and Validation of a Liquid Chromatographic Method to Quantify Sucrose, Glucose, and Fructose in Tubers of Solanum Tuberosum Group Phureja. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 2015, 975, 18–23.
Wilson A.M.; Work, T.M.; Bushway, A.A.; Bushway, R.J. HPLC Determination of Fructose, Glucose, and Sucrose in Potatoes. J. Food Sci., 1981, 46, 300–301.
Wahjudi, P.N.; Patterson, M.E.; Lim, S.; Yee, J.K.; Mao, C.S.; Lee, W.N.P. Measurement of Glucose and Fructose in Clinical Samples Using Gas Chromatography/Mass Spectrometry. Clin. Biochem., 2010, 43, 198–207.
Parpinello, G.P.; Versari, A. A Simple High-Performance Liquid Chromatography Method for the Analysis of Glucose, Glycerol, and Methanol in a Bioprocess. J. Chromatogr. Sci., 2000, 38, 259–261.
Wang, J. Electrochemical Detection for Capillary Electrophoresis Microchips: A Review. Electroanalysis, 2005, 17, 1133–1140.
Mattila, P.; Kumpulainen, J. Determination of Free and Total Phenolic Acids in Plant-Derived Foods by HPLC with Diode-Array Detection. J. Agric. Food Chem., 2002, 50, 3660–3667.
Al-Sanea, M.M.; Gamal, M. Critical Analytical Review: Rare and Recent Applications of Refractive Index Detector in HPLC Chromatographic Drug Analysis. Microchem. J., 2022, 178, 107339.
Bao, Y.; Silva, T.M.J.; Guerrant, R.L.; Lima, A.A.M.; Fox, J.W. Direct Analysis of Mannitol, Lactulose and Glucose in Urine Samples by High-Performance Anion-Exchange Chromatography with Pulse Amperometric Detection. Clinical Evaluation of Intestinal Permeability in Human Immunodeficiency Virus Infection. J. Chromatogr. B Biomed. Appl., 1996, 685, 105–112.
Mourey, T.H.; Oppenheimer, L.E. Principles of Operation of an Evaporative Light-Scattering Detector for Liquid Chromatography. Anal. Chem., 1984, 56, 2427–2434.
Moreau, R.A. The Analysis of Lipids via HPLC with a Charged Aerosol Detector. Lipids, 2006, 41, 727–734.
