Volume : 09, Issue : 06, June – 2022



Authors :

Sonali Agarkar

Abstract :

A UV spectrophotometry and RP-HPLC method for the Gliclazide tablets quantification in the developed method is described. Both the methods were validated according to ICH Q2 R (1) guidelines for linearity, accuracy, precision, the limit of detection, the limit of quantification, specificity, and robustness. HPLC was run in isocratic mode on a reversed-phase C18 column (250×4.6 mm internal diameter and particle size of 5 μm) ACN: Water: TEA: TFA (50:50:0.1:0.1) as the mobile phase maintaining a flow rate of 1.0 ml/min. Gliclazide drug showed an absorbance maximum (λmax) in methanol 228 nm and 7.4 pH phosphate buffer solution 226 nm which was used for the UV spectrophotometry determinations. The calibration curve of the Gliclazide drug showed linearity in the required concentration range (R2>0.999) by both the UV and HPLC methods. Both the methods were found to be precise and accurate with a recovery range of 98–101% and a relative standard deviation <2%. Most importantly, the accuracy and precision achieved by the HPLC method, correlated closely with the UV method. The current study also involves the detection and quantification of Gliclazide drug released from its formulations by both the developed methods. This paper demonstrates the high correlation (R2≥0.98) between the UV and HPLC methods when determining the release of the Gliclazide drug from various formulations. With this established correlation, we hereby suggest that, for routine analysis, UV spectrophotometry can be an economic, simple, reliable, and less time-consuming alternative to expensive and time-consuming Chromatographic analysis.
Keywords: Gliclazide drug, UV spectrophotometry, High-Performance Liquid Chromatography method, Validation study

Cite This Article:

Please cite this article in press Sonali Agarkar , Quantification Of Gliclazide Tablets And Their Formulations: HPLC And UV Spectrophotometry Methods.,Indo Am. J. P. Sci, 2022; 09(6).,

Number of Downloads : 10


[1] Hong S.S, Lee S.H, Lee Y.J, Chung S.J, Lee M.H, Shim S.K: Accelerated oral absorption of Gliclazide in human subjects from a soft gelatin capsule containing a peg 400 suspension of Gliclazide, J. Control. Release (1998) 51; 185–192.
[2] Sarkar A, Tiwari A, Bhasin P.S, Mitra M.: Pharmacological and pharmaceutical profile of Gliclazide: a review, J. Appl. Pharm. Sci (2011) 09; 11–19.
[3] Ahmed Gedawy, Hani Al-Salami, Crispin, R. Dass: Development and validation of a new analytical HPLC method for simultaneous determination of the anti-diabetic drugs, metformin, and Gliclazide, J Food Drug Anal,(2019) 27; 315-322.
[4] Shuai Yu, Yan Cheng, Wenguo Xing, Fumin Xue: Solubility determination and thermodynamic modeling of gliclazide in five binary solvent mixtures, J. Mol. Liq, (2020) 311;113258.
[5] T. Peters, All About Albumin: Biochemistry, Genetics, and Medical Applications, Mol Nutr Food Res, (2006) 41;382.https://doi.org/10.1002/food.19970410631.
[6] Ewa Żurawska-Płaksej, Anna Rorbach-Dolata, Katarzyna Wiglusz, Agnieszka Piwowar: The effect of glycation on bovine serum albumin conformation and ligand binding properties with regard to Gliclazide, Spectrochim. Acta A Mol. Biomol, (2018) 189; 625-633.
[7] Weiguo Li, Kimiko Ota, Nakamura, Naruse Keiko, Nakashima, Hamada Yoji: Brief Communication: Antiglycation effect of Gliclazide on in vitro AGE formation from glucose and methylglyoxal, Exp. Biol. Med (2008) 233; 176-179.
[8] Kim H, Yun M, Kwon K.I: Pharmacokinetic and pharmacodynamic characterization of Gliclazide in healthy volunteers, Arch. Pharm. Res. (2003) 26: 564–568.
[9] Sonali Agarkar: formulation and development of sustained released Gliclazide tablets with the different hydrophilic polymer by using direct compression technique, IJSREM, (2021) 5: 1-18.
[10] Shaik, M., Shaik, S. and Kilari, E.K: Population pharmacokinetics of Gliclazide in normal and diabetic rabbits, Biopharm Drug Dispos, (2018) 39: 265-274. [11] Durig T, Lusvardi K.M, Harcum W.W: Hydroxyl propyl cellulose in Modified Release Matrix Systems: Polymer Molecular weight Controls Drug Release Rate and Mechanism, Pharmaceutical technology report, Pharm. Technol. (2011): 1-7.
[12] Fukui S, Yano H, Yada S, Mikkaichi T, and Minami H: Design, and evaluation of an extended-release matrix tablet formulation the combination of hypromellose acetate succinate and hydroxypropyl cellulose, Asian J. Pharm. Sci. (2017) 12: 149-156. [13] Han X.W, Zhang H.W, Luo H.Y, Zheng X.L, Yang Z, Liao Y.J, Yang: Preparation of Poly(vinyl alcohol) microspheres based on droplet microfluidic technology, Chinese J. Anal. Chem. (2018) 46: 1269- 1274.
[14] Kanae FI, Kokkalou E, Georgarakis M, Niopas: A validated solid-phase extraction HPLC method for the simultaneous determination of the citrus flavanone aglycones hesperetin and naringenin in urine. J Pharm Biomed Anal (2004) 36:175–181. https:// doi.org/10.1016/j.jpba.2004.05.015.
[15] Aradhana K, Pillai K.V, Khileshwari Gautam, Archana Jain, Krishna K, Verma,Headspace in-drop derivatization of carbonyl compounds for their analysis by high-performance liquid chromatography diode array detection, Anal Chim Acta,(2008) 632:208-215, DOI:10.1016/j.aca.2008.11.021
[16] Chowdary, K.P.R, and Ramya K: Recent research on co-processed excipients for direct compression a review, Pharmacie Globale, Int J. compr. Pharm. (2013) 4: 1.
[17] Gulshan Bansal, Manjeet Singh Kaur: Forced degradation study on gliclazide and application of validated stability-indicating HPLC-UV method instability testing of Gliclazide tablets, Chromatographia (2007) 66:751-755.
[18] Vijayalakshmi, P, Devi, V.K, Devi, K, Benson, M.K, and Srinagesh S: Formulation development and in vivo characterization of solubility enhanced gliclazide tablets, Curr Trends Biotechnol Pharm. (2008) 2: 456-461.