Analytical Method Development and Validation for the Simultaneous Estimation of Miglitol and Metformin HCL

Pancheddula Munija, Banothu Sunita, Malagam Mithila — Thu, 05 Nov 2026 00:00:00 +0000

Background: Reliable simultaneous quantification of miglitol and metformin hydrochloride is important for analysing combined pharmaceutical dosage forms.

AIM: This study aimed to develop and validate a reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of miglitol and metformin hydrochloride in bulk drug materials and a combined tablet formulation.

Study Design: The method was optimised and evaluated for system suitability, specificity, linearity, accuracy, precision, and robustness under the reported validation conditions.

Methodology: Separation was performed on a Phenomenex Gemini C18 column (4.6 × 250 mm, 5 µm) using methanol and triethylamine buffer (65:35, v/v), at a flow rate of 1.0 mL/min, with detection at 230 nm and a 10 µL injection volume.

Results: Retention times: Miglitol and metformin eluted at 2.121 and 3.643 minutes, respectively, within a six-minute run. Linearity: The calibration ranges were 10–50 µg/mL for miglitol and 20–100 µg/mL for metformin. The respective coefficients of determination (R²) were 0.999 and 0.998, with regression equations of y = 13396x + 2467 and y = 27563.38x − 15679.38. Recovery: The reported mean recoveries were 99.7% for miglitol and 98.5% for metformin. Precision and sensitivity: The precision relative standard deviations (RSDs) were 0.672% and 0.266%, respectively. The limits of detection (LOD) were 1.05 and 6.9 µg/mL, and the limits of quantification (LOQ) were 3.1 and 20.9 µg/mL for miglitol and metformin, respectively.

Conclusion: The reported separation, linearity, recovery and precision results support the potential use of the developed RP-HPLC procedure for simultaneous quantification of both analytes in the pharmaceutical preparation investigated.

Nanotechnology in Neuroprotection: Mechanistic Opportunities, Delivery Constraints and Translational Priorities

Thu, 22 Oct 2026 00:00:00 +0000

Nanotechnology is increasingly used to alter the pharmacokinetics, cellular distribution and biological activity of putative neuroprotective agents, yet enhanced brain delivery should not be equated automatically with neuroprotection. This critical narrative review evaluates nanotechnology-enabled neuroprotection across the blood-brain barrier and neurovascular unit, with emphasis on whether platform design produces credible neuronal preservation rather than only improved uptake. Literature published from 2005 to 8 August 2026 was considered, together with earlier foundational work when necessary, using live searches of biomedical and multidisciplinary scholarly sources and citation-based verification. The synthesis focuses on lipid and polymeric nanocarriers, dendrimers, inorganic nanozymes, biomimetic systems and intranasal approaches, and compares evidence across Alzheimer disease, Parkinson disease, ischaemic stroke, traumatic brain injury and selected inflammatory or developmental central nervous system injuries. Preclinical evidence is most persuasive when carrier behaviour, target engagement and a defined injury mechanism converge, as illustrated by catalytic antioxidant nanomaterials, glia-targeted anti-inflammatory dendrimers and nanoparticle strategies directed at secondary injury cascades. In chronic neurodegeneration, by contrast, improvements in biodistribution or molecular target engagement frequently outpace evidence for durable disease modification. Disease-dependent blood-brain barrier dysfunction, protein-corona formation, cell-specific uptake, nanoparticle persistence, neurotoxicity, route-dependent exposure and manufacturing variability remain major sources of uncertainty. The translational problem is therefore not simply how to cross the blood-brain barrier, but how to achieve reproducible exposure in the relevant brain compartment at the relevant disease stage while preserving safety and demonstrating meaningful functional benefit. Progress will depend on human-relevant barrier models, quantitative biodistribution and target-engagement standards, chronic safety studies, scalable chemistry and manufacturing controls, and clinically aligned outcome selection. Nanotechnology is best viewed as an enabling framework for neuroprotection rather than an intrinsically neuroprotective class of therapy.

Journal of Pharmaceutical Research International

Analytical Method Development and Validation for the Simultaneous Estimation of Miglitol and Metformin HCL

Nanotechnology in Neuroprotection: Mechanistic Opportunities, Delivery Constraints and Translational Priorities