Research Journal of Pharmacy and Technology

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Development and Validation of a Rp-uhplc Method for Estimation Of Gliclazide Loaded Microsphere


Affiliations
1 Girijananda Chowdhury Institute of Pharmaceutical Science, Tezpur, Assam – 784501., India
2 Assam Science and Technology University, Jalukbari, Guwahati, Assam-781013., India
3 NETES Institute of Pharmaceutical Science, Mirza, Kamrup, Assam-781125., India
     

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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.

Keywords

Gliclazide, RP-UHPLC, Validation, Microsphere, Drug Entrapment Efficiency.
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  • Development and Validation of a Rp-uhplc Method for Estimation Of Gliclazide Loaded Microsphere

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Authors

Abdul Baquee Ahmed
Girijananda Chowdhury Institute of Pharmaceutical Science, Tezpur, Assam – 784501., India
Ripunjoy Bordoloi
Assam Science and Technology University, Jalukbari, Guwahati, Assam-781013., India
Kunal Bhattacharya
NETES Institute of Pharmaceutical Science, Mirza, Kamrup, Assam-781125., India

Abstract


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.

Keywords


Gliclazide, RP-UHPLC, Validation, Microsphere, Drug Entrapment Efficiency.

References