QbD BASED RP-HPLC METHOD DEVELOPMENT FOR FIVE FLUOROQUINOLONE ANTI-BACTERIALS - THROUGH CREATION OF DESIGN SPACE FOR CRITICAL ATTRIBUTES
Journal Title: International Journal of Pharmaceutical Sciences and Research (IJPSR) - Year 2019, Vol 10, Issue 11
Abstract
Quality by Design (QbD) has become an important concept for the pharmaceutical industry, and ICH recommends this concept through the Guideline Q8 (R2) wherein if the method is proved to be rugged and robust within the limits of a Design Space then approval may be requested for such a Design Space, and the method does not need redevelopment, revalidation, and reapproval during transfers, thereby saving significant time and resources. In this study, the QbD approach was used to develop a reverse-phase–high-performance liquid chromatography (RP–HPLC) method that could be applied for the estimation of several antibacterial agents of the fluoroquinolone group. The method was applied to five selected fluoroquinolones, namely, ciprofloxacin, levofloxacin, norfloxacin, moxifloxacin, and ofloxacin. The method developed used C18 column of make Phenomenex (250 mm × 4.6 mm, 5 μm) with mobile phase comprising of methanol and phosphate buffer (pH 3.0) in the proportion 70:30 at a flow rate of 1.25 ml/min and detection was carried out using a PDA detector at 294 nm. The method while being validated as per ICH guidelines, using ANOVA, simultaneously created a design space which set limits for critical attributes affecting the robustness. Any variations in these parameters within the design space does not affect method performance, making the method easily transferrable.
Authors and Affiliations
S. S. Kudchadkar et al.
Keywords
Related Articles
- EP ID EP665038
- DOI 10.13040/IJPSR.0975-8232.10(11).4907-12
- Views 95
- Downloads 0
SYNTHESIS AND CHARACTERIZATION OF SILVER NANOPARTICLES AND EVALUATION OF ANTIMICROBIAL ACTIVITY OF LEAF, SEED AND FRUIT EXTRACTS OF SYZYGIUM CUMINI L.
Syzygium cumini L. belongs to the family Myrtaceae is one of the widely used medicinal plants in the treatment of various diseases particularly diabetes. The present study has been focused on the synthesis of silver nano...
IN-VITRO COMPARATIVE ANTICANCER ACTIVITY STUDY OF METHANOLIC EXTRACT OF TRADITIONALLY USED MEDICINAL PLANT OF MIZORAM
Objective: The present study explores the anticancer potentially of plant sample based on the evidence from the ethnomedicinal practice of the plant. The main objective was to find out the in-vitro comparative anticancer...
ALPHA-AMYLASE INHIBITION AND MEMBRANE STABILIZING EFFECT OF THE STEM BARK OF MAESOBOTRYA DUSENII HUTCHINSON
Introduction: Control of blood glucose level is a critical approach in the management of diabetes mellitus and its complications. This study investigated the α-amylase inhibition and erythrocyte membrane stabilization ef...
DEVELOPMENT AND VALIDATION OF A NEW HPLC-UV METHOD FOR SIMULTANEOUS ESTIMATION OF CETIRIZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE IN TABLET FORMULATION
A simple, rapid, and sensitive high-performance liquid chromatographic method with UV detection has been developed and validated according to the ICH guidelines for the quantitation of Cetirizine Hydrochloride (CET) and...
PREVALENCE OF ANEMIA AND ITS ASSOCIATED FACTORS AMONG PREGNANT WOMEN ATTENDING ANTENATAL CENTER IN SHARJAH, UAE
Anemia during pregnancy is a common complication which can involve a mother’s health, baby’s health, or both. Socioeconomic status is affecting the prevalence of maternal anemia, which is varied substantially across regi...