1Girijananda Chowdhury Institute of Pharmaceutical Science, Tezpur, Assam - 784501
2Assam Science and Technology University, Jalukbari, Guwahati, Assam-781013
3NETES Institute of Pharmaceutical Science, Mirza, Kamrup, Assam-781125
*Corresponding Author E-mail: kunal22101994@gmail.com
Online published on 13 June, 2022.
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.
The chromatographic analysis was carried out on Thermo Scientific (Dionex Ultra 3000plus) UHPLC using a stainless steel YMC C8 column (25cm x 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.
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%
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.
Gliclazide, RP-UHPLC, Validation, Microsphere, Drug Entrapment Efficiency
