Scholarlink

<p>The simultaneous quantification bulk active pharmaceutical components and combined dosage forms is vital for ensuring quality control and therapeutic efficacy. This study addresses the need for a reliable analytical method for the simultaneous quantification of lobeglitazone sulphate (LBZ) and glimepiride (GPR), two drugs often used in the administration of type 2 diabetes. A review of existing literature reveals the absence of a quality by design (QbD)-assisted reverse phase high-performance liquid chromatography (RP-HPLC) method for this specific combination. Using a QbD approach, a robust RP-HPLC method was developed and optimized employing a central composite design (CCD). The Agilent Infinity 1270 Series HPLC system, equipped with a Zorbax SB 618 column (5&#xa0;μm, 46 × 150&#xa0;mm), was used. Method parameters were fine-tuned to achieve optimal resolution (7.6), tailing (1.8), and retention times of 5.6&#xa0;min for LBZ and 8.6&#xa0;min for GPR. The optimized mobile phase consisted of ACN:KH₂PO₄ buffer (pH 3.5, 50:50 v/v), a flow rate of 1&#xa0;mL/min, and a detection wavelength of 227&#xa0;nm. The developed method was validated as per current regulatory guidelines, demonstrating precision, accuracy, and sensitivity. These results underscore the effectiveness of a QbD framework in method development, ensuring reproducibility and robustness. This study highlights the broader potential of QbD-assisted analytical techniques in pharmaceutical research, paving the way for more efficient drug quality assessments and improved therapeutic outcomes across diverse drug combinations.</p> Graphical Abstract <p></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Development and Validation of QBD-Assisted Using Central Composite Design RP-HPLC Method for Lobeglitazone Sulfate and Glimipiride in Bulk and Its Combined Dosage Form

  • 期刊论文

  • 发表日期：

    2025年4月4日

查看全文
  • A. Marina Juliet,
  • Punniyakoti Veeraveedu Thanikachalam

摘要

The simultaneous quantification bulk active pharmaceutical components and combined dosage forms is vital for ensuring quality control and therapeutic efficacy. This study addresses the need for a reliable analytical method for the simultaneous quantification of lobeglitazone sulphate (LBZ) and glimepiride (GPR), two drugs often used in the administration of type 2 diabetes. A review of existing literature reveals the absence of a quality by design (QbD)-assisted reverse phase high-performance liquid chromatography (RP-HPLC) method for this specific combination. Using a QbD approach, a robust RP-HPLC method was developed and optimized employing a central composite design (CCD). The Agilent Infinity 1270 Series HPLC system, equipped with a Zorbax SB 618 column (5 μm, 46 × 150 mm), was used. Method parameters were fine-tuned to achieve optimal resolution (7.6), tailing (1.8), and retention times of 5.6 min for LBZ and 8.6 min for GPR. The optimized mobile phase consisted of ACN:KH₂PO₄ buffer (pH 3.5, 50:50 v/v), a flow rate of 1 mL/min, and a detection wavelength of 227 nm. The developed method was validated as per current regulatory guidelines, demonstrating precision, accuracy, and sensitivity. These results underscore the effectiveness of a QbD framework in method development, ensuring reproducibility and robustness. This study highlights the broader potential of QbD-assisted analytical techniques in pharmaceutical research, paving the way for more efficient drug quality assessments and improved therapeutic outcomes across diverse drug combinations.

Graphical Abstract