NIKHIL ARUN SHETE*, DR. ANIL PAWAR, VAIJAYANTI LOKHANDE, VISHWAJEET SWAMI, DR. V. K. DESHMUKH

¹Mula Education Societys College of Pharmacy, Sonai, Ahemadnagar, Newasa, Maharashtra-414105.

²Mula Education Societys College of Pharmacy, Sonai, Ahemadnagar, Newasa, Maharashtra-414105.

³Mula Rural Institute College of Pharmacy Sonai, Ahemadnagar, Newasa, Maharashtra-414105.

⁴Dr. D.Y. Patil institute of Pharmaceutical Sciences and Research Pimpri Pune - 18.

⁵Mula Education Societys College of Pharmacy, Sonai, Ahemadnagar, Newasa, Maharashtra-414105.

Corresponding Author: Nikhil Arun Shete, Mula Education Societys College of Pharmacy, Sonai, Ahemadnagar, Newasa, Maharashtra-414105. Email Id: nikhilshete300@gmail.com

Citation: Nikhil Arun Shete, Dr. Anil Pawar, Vaijayanti Lokhande, Vishwajeet Swami, Dr. V.K. Deshmukh (2021) QBD Based Development and Validation of a Stability Indicating UHPLC Method for Pioglitazone And Glimepiride. J Pharm Exper Med, 2(2);1-8.

Copy Rights: © 2021, Nikhil Arun Shete. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.

ABSTRACT:

Quality by Design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. In an attempt to reduce rising development costs and regulatory barriers to innovation and creativity. In the pharmaceutical world, is considered as any other organic material, besides the drug substance, or ingredients arise out of synthesis or an unwanted chemical that remains with API’s. The present study describes a simple, accurate, precise and cost effective Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for determination pioglitazone and Glimepiride from bulk and formulation. RP-HPLC method was developed to identify and quantify the pioglitazone and Glimepiride in bulk and formulation as per ICH Q2 (R1) guidelines. Optimization was done by response surface methodology, applying a three level full factorial design. Two factors selected were methanol concentration in mobile phase, and flow rate. The separation was carried out using gilent 4.5 X 100mm 2.5um column. Detection was done using UV detector at 225nm. The developed method employed mobile phase methanol: (0.1%) water (75:25) (pH 3.2) temperature 27℃ and flow rate 0.7 ml/min, which was optimized with the help of design expert software. High linearity of the developed method was confirmed over concentration range of 15-75&2-10 μg/mL for pioglitazone and Glimepiride with correlation coefficient of 0.998 and 0.999. The percentage RSD for precision and accuracy of the method was found to be less than 2%. Peaks were obtained at retention times of 2.9333 & 6.9667 min respectively for pioglitazone and Glimepiride The proposed method can be successfully used to determine the drug contents of marketed formulation.

KEYWORDS:

Quality By Design, Reverse Phase High Performance Liquid Chromatographic, Pioglitazone, Glimepiride, Optimization, Mobile Phase.