Analytical Method Development and Validation for the Simultaneous Estimation of Miglitol and Metformin HCL
Pancheddula Munija
*
Department of Pharmaceutics, Samskruti College of Pharmacy, Ghatkesar, Hyderabad, Telangana, India.
Banothu Sunita
Department of Pharmacy, Chaitanya Deemed to be University, Hyderabad, India.
Malagam Mithila
Department of Pharmaceutical Analysis, Vision College of Pharmaceutical Sciences & Research, Telangana, India.
*Author to whom correspondence should be addressed.
Abstract
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.
Keywords: RP-HPLC, miglitol, metformin, validation, development