Deduction of the operable design space of RP-HPLC technique for the simultaneous estimation of metformin, pioglitazone, and glimepiride

Abstract

A reversed-phase RP-HPLC method was developed for the simultaneous determination of metformin hydrochloride (MET), pioglitazone (PIO), and glimepiride (GLM) in their combined dosage forms and spiked human plasma. Quality risk management principles for determining the critical method parameters (CMPs) and fractional factorial design were made to screen CMPs and subsequently, the Box–Behnken design was employed. The analytical Quality by Design (AQbD) paradigm was used to establish the method operable design region (MODR) for the developed method depended on understanding the quality target product profile (QTPP), analytical target profile (ATP), and risk assessment for different factors that affect the method performance to develop an accurate, precise, cost-effective, and environmentally benign method. The separation was carried out using a mobile phase composed of methanol: 0.05 M potassium dihydrogen phosphate buffer pH 3.7 with 0.05% TEA (78:22, v/v). The flow rate was 1.2 mL/min. DAD detector was set at 227 nm. Linagliptin (LIN) was used as an internal standard. The proposed method was validated according to The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The assay results obtained by using the developed method were statistically compared to those obtained by the reported HPLC method, and a satisfying agreement was observed.

An integrated framework to develop an efficient valid green (EVG) HPLC method for the assessment of antimicrobial pollutants with potential threats to human health in aquatic systems

“…Then, the risk assessment tool for the factors affecting the performance of the method is identified by studying the CMPs that influence CQAs. 50–52…”

“…Then, the risk assessment tool for the factors affecting the performance of the method is identied by studying the CMPs that inuence CQAs. [50][51][52] The HPLC process is inuenced by numerous factors, some of which must be discarded because they do not have a signicant impact. Risk assessment determined the selected (CQAs) in relation to several CMPs, which are represented in the Ishikawa diagram, as shown in Fig.…”

Quantitative determination of lobeglitazone sulfate and glimepiride in combined tablet by robust high‐performance thin layer chromatographic method

“…Ultraviolet spectrophotometry [15][16][17][18][19][20][21], highperformance liquid chromatography (HPLC) [22][23][24][25][26][27][28][29][30], high-performance thin-layer chromatography (HPTLC) [31][32][33][34][35][36][37], liquid chromatography-mass spectrometry (LC-MS) [38][39][40][41][42][43][44], and gas chromatography-mass spectrometry (GC-MS) [45] are among the analytical approaches stated in the literature for quantifying the concentrations of LBZ and GLM separately or in blend with other substances, in bulk drug samples or pharmaceutical formulations. Only two analytical methods have been reported [22,23] for determining LBZ individually, and these methods cannot be used to estimate the drugs in combined formulations.…”

Densitometric simultaneous assessment of teneligliptin hydrobromide and pioglitazone hydrochloride in combined tablet

“…A review of the existing literature focusing on the quantitative analysis of TGT and PGZ indicated that efforts have been directed toward devising analytical methods for these individual drugs, as well as in combination with other medications. These efforts have resulted in developing various methods including UV spectroscopy [3,[12][13][14][15], HPLC [2,3,7,[16][17][18][19][20][21][22][23], high-performance thin-layer chromatography (HPTLC) [15,[24][25][26][27][28][29], and LC-MS [23,[30][31][32][33][34][35][36]. Among the various methods that have been reported, the work by Gheewala et al in 2017 provided a comprehensive account of simultaneously determining TGT and PGZ within a synthetic mixture using both UV spectroscopy and HPLC.…”