Analytical Method Development and Validation of Gliclazide using RP-HPLC from Pharmaceutical Dosage Form

Author: Shweta H. Shahare, Dipti G. Phadtare, Hitesh V. Shahare, Yunus N. Ansari, Bhavesh B. Amrute, Sagar S. Vidhate and Sachin N. Kapse

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Abstract

Elevated sugar levels brought on by a lack of insulin are a defining feature of diabetes mellitus. The sulfonylurea class of insulin secretagogues, which includes gliclazide, is a second-generation hypoglycemic drug that works by boosting insulin secretion from beta cells in the pancreatic Islet of Langerhans. Developing a selective method for accurate measurement in pharmaceutical dosage forms is challenging due to potential interference from excipients. This study gives valuable insights into optimizing chromatographic parameters, including mobile phase composition, and pH, to enhance the separation, resolution, and peak symmetry of Gliclazide. The procedure was designed utilizing a 4.6 mm × 250 mm, 5 Hypersil OSD C18 column at 25 °C, 1.0 mL/min flow rate, 20 L volume, and a run time of 15 minutes at a wavelength of 228 nm with phosphate buffer: Acetonitrile (10:90 v/v) maintained at pH3 as the mobile phase. System appropriateness, specificity, precision (system and technique), accuracy, linearity, ruggedness, robustness, the limit of detection (LOD), and the limit of quantitation (LOQ) were all evaluated for the developed method. The validated approach can be utilized for the regular analysis of Gliclazide from pharmaceutical dosage forms because it was discovered to be quick, accurate, sensitive, and precise.

Keywords

Gliclazide, Diabetes, Insulin, Validation, RP-HPLC

Conclusion

In conclusion, the development and validation of a reverse phase RP-HPLC method for the estimation of Gliclazide in pharmaceutical dosage form have been successfully achieved. This method provides a simple and accurate alternative to existing methods. The method demonstrated high accuracy and sensitivity in the estimation of Gliclazide, which is an important type 2 anti-diabetic drug (Sabhyatha et al., 2022). The method developed uses HPLC Schimadzu Model LC-2030 PLUS (IND)with a PDA detector made up of a Thermo - Hypersil ODS, C18, 4.6 mm × 250 mm. This method can be used for the analysis of both Gliclazide in raw materials and finished products. The reverse phase RP-HPLC method developed in this study offers a simple and effective means of estimating Gliclazide in pharmaceutical dosage form with high accuracy and sensitivity. Moreover, this method presents an affordable and less complex alternative to traditional methods. Furthermore, the method developed can be used for the analysis of both Gliclazide in raw materials and finished products.

References

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How to cite this article

Shweta H. Shahare, Dipti G. Phadtare, Hitesh V. Shahare, Yunus N. Ansari, Bhavesh B. Amrute, Sagar S. Vidhate and Sachin N. Kapse (2023). Analytical Method Development and Validation of Gliclazide using RP-HPLC from Pharmaceutical Dosage Form. Biological Forum – An International Journal, 15(5): 786-792.