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

Author:

Ahmed Abdul Baquee1,Bordoloi Ripunjoy2,Bhattacharya Kunal3

Affiliation:

1. Girijananda Chowdhury Institute of Pharmaceutical Science, Tezpur, Assam – 784501.

2. Assam Science and Technology University, Jalukbari, Guwahati, Assam-781013.

3. NETES Institute of Pharmaceutical Science, Mirza, Kamrup, Assam-781125.

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.

Publisher

A and V Publications

Subject

Pharmacology (medical),Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference21 articles.

1. Sarkar A, Tiwari A, Bhasin PS et al. Pharmacological and pharmaceutical profile of gliclazide: A review, J. Appl. Pharm. Sci. 1; 2011: 11–19.

2. Delrat P, Paraire M, Jochemsen R. Complete bioavailability and lack of food-effect on pharmacokinetics of gliclazide 30 mg modified release in healthy volunteers, Biopharm. Drug Dispos. 23; 2002: 151–157.

3. ICH, Q2 (R1) validation of analytical procedures: text and methodology, Proceedings of the International Conference on Harmonization, November 1996.

4. ICH, Q1A (R2) stability testing of new drug substances and products, Proceedings of the International Conference on Harmonization, November 1996.

5. Donnell PB, McGinity JW. Preparation of microspheres by the solvent evaporation technique, Adv. Drug Deliv. Rev. 28; 1997: 25–42.

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3