Quality by Design (QbD) Approach to Develop and Validate a HPLC Method for Piroxicam from Serum

Abstract

Piroxicam belongs to the non-steroidal antiinflammatory class, it is utilized as analgesic, anti-inflammatory and antipyretic. A simple and accurate HPLC method was optimized and validated in the QbD approach, for the determination of piroxicam in serum. The optimization of HPLC analysis was performed using different columns, mobile phases and flows. The HPLC method was appropriately validated for linearity, limit of detection, limit of quantification, precision and accuracy in accordance with the ICH guidelines. The optimized and validated method proved to be simple, precise, and accurate, and can be successfully applied for the determination of piroxicam in serum.

Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Metformin Hydrochloride in Tablet Dosage Forms by HPLC

“…In the case of HPLC methods, the CMPs with high risk assessment are those regarding the material, instrumental parameters, mobile phase (buffer type, concentration, and pH, organic modifier, elution method), column characteristics and preparation, and the analyst. In general, for risk identification and assessment, Ishikawa fishbone diagram can be used (Figure 2) [42][43][44][45][46].…”

“…In the case of HPLC methods, the CMPs with high risk assessment are those regarding the material, instrumental parameters, mobile phase (buffer type, concentration, and pH, organic modifier, elution method), column characteristics and preparation, and the analyst. In general, for risk identification and assessment, Ishikawa fishbone diagram can be used (Figure 2) [42][43][44][45][46]. In short, the necessary steps in developing an analytical method with the implementation of QbD principles are as follows: Project initiation → Literature search and initial risk assessment → Identification of ATP, CMAs, risk assessment → Method optimization and method development with DOE → MODR, Control Strategy and Risk Assessment → AQbD method validation → Continuous method monitoring.…”

Direct determination of piroxicam in pharmaceutical forms using flow injection- spectrophotometry

“…Therapeutic dose of PIX is 20 mg daily, but it can cause several gastrointestinal upset symptoms at high dose [2], therefore, the assay of PIX is recommended to gain the optimal therapeutic level and to ensure good quality assurance in pharmaceutical products. PIX has been determined by several reported methods included high performance liquid chromatography (HPLC) [3,4], extraction by magnetic imprinted polymeric nanosorbent [5], ultrasonic assisted magnetic dispersive solid phase microextraction [6], capillary electrophoresis (CE) [7,8], and voltammetry [9]. The literature reported several spectrophotometric methods [10][11][12][13][14][15][16][17][18][19][20] and a few flow injection methods [21][22][23][24] for the determination of PIX in dosage forms.…”

The Influence of the Structure of Several New ortho-Hydroxy-Ketone Derived bis-Schiff Bases on Their Antibacterial and Anti-Inflammatory Activity

“…The biological activities of the Schiff bases have been attracting the attention of researchers of Organic Chemistry and Medicine. Nowadays, Schiff bases are well known for their importance as anticancer [2], antimicrobial [3,4], anti-inflammatory [5][6][7][8], antiviral [9], analgesic [10], and anti-oxidizing [11][12][13][14][15] agents but a systematic study regarding their structureactivity relationship has not been reported so far. That was the reason why, we have started a complex study by designing Schiff bases that contained different halogens in different positions and vicinities, with the aim of clarifying the role of these groups in their antimicrobial and anti-inflammatory activity.…”

“…The inflammation is determined by chemical mediators, which present various structures. Several studies proved that bis-Schiff bases reduced the synthesis of some chemical mediators of acute inflammation such as leukotrienes which are implicated in the formation of free radicals [9,[12][13][14][15][16][17][18].…”