Development and Validation of a RP-UHPLC Method for estimation of Gliclazide loaded Microsphere

• Published in: Research journal of pharmacy and technology 2022-02, Vol.15 (2), p.773-778
• Main Authors: Ahmed, Abdul Baquee, Bordoloi, Ripunjoy, Bhattacharya, Kunal
• Format: Article
• Language: English
• Subjects: Chromatography; Diabetes; Efficiency; Fourier transforms; Membrane filters; Particle size; Stainless steel
• ISSN: 0974-3618; 0974-360X; 0974-306X
• DOI: 10.52711/0974-360X.2022.00129

Objective: The objective of the current work is to develop and validate a simple yet effective, efficient and reproducible RP-UHPLC method for the determination of Gilcazide loaded in a microsphere formulation. Methods: The chromatographic analysis was carried out on Thermo Scientific (Dionex Ultra 3000plus) UHPLC using a stainless steel YMC C8 column (25cm × 4mm) packed with endcapped octylsilane bonded to porous silica (4µm) in isocratic elution mode using phosphate buffer pH 3.4 and HPLC grade acetonitrile in the ratio of 20: 80 (v/v) as eluent. The flow rate was adjusted as 1ml/min and eluent was detected at 230 nm. The retention time was observed at 1.9 min. Results: The linear dynamic range for the developed UHPLC method was found in the concentration range of 2-10µg/ml and percentage recovery was in the range of 94%-98%. Drug Entrapment Efficiency Data of Gliclazide loaded microsphere was found to be 93.72% Conclusion: In this RP–UHPLC method, the linearity was within the range of 2–10μg/mL and the validation parameters were within the limits was performed as per ICH guidelines. The % Drug entrapment Efficiency of the Gliclazide loaded microsphere was found to be 93.72 % which was satisfactory.