RP-LC Simultaneous Quantitation of Fixed Medication Combination Drugs for Diabetic Mellitus in Active Pharmaceutical Ingredient and Pharmaceutical Commercial Formulations with Pda-Detector

Objective: The gliclazide (GZE), metformin (MTN), and rosiglitazone (RZE) fixed medication combinations proved to have enhanced glucose control in diabetic patients. Aliquid chromatography-photodiode array (LC-PDA) method for the determination of GZE, MTN, and RZE in bulk and pharmaceutical dose form was developed because no validated simultaneous RP-LC-PDA method for this triple combination was found. Methods: The analysis of GZE, MTN, and RZE was made using Agilent C18 Eclipse XBD column and 60% volume of 0.01% trimethylamine buffer, pH adjusted to 2.5 with orthophosphoric acid: 40% volume of acetonitrile as a mobile phase. Wavelength, 231 nm was used for the detection of GZE, MTN, and RZE. The developed methodology was validated in accordance with ICH requirements. The formulation samples containing GZE, MTN, and RZE were subjected to oxidative, acid, hydrolytic, base, thermal, and light stress treatments during the forced degradation experiments. Results: The described LC-PDA method allowed rapid and simultaneous determination of GZE, MTN, and RZE in both bulk powders and tablet formulations. Adequate linear behaviour was seen in the concentration range: 10 to 60 µg/ml (GZE), 125 to 750 µg/ml (MTN), and 0.5 to 3.0 µg/ml (RZE). The LOQ value for GZE was 0.120µg/ml, MTN was 1.500 µg/ml and RZE was 0.006µg/ml. All validated parameters [robustness-0.308% to 1.037% RSD, ruggedness-0.662% to 1.068% RSD, precision-0.662% to 1.774% RSD, accuracy-99.10 – 100.35% recovery) stayed within the permitted limits, confirming the robustness, ruggedness, precision, accuracy and applicability related to the developed LC-PDA technique. The LC-PDA represents stability-indicating since good separation exists between GZE, MTN, and RZE and the degradation products during stress treatments. Conclusion: This method may be utilised to evaluate the GZE, MTN, and RZE for routine analysis in tablet formulations as well as stability investigations of GZE, MTN, and RZE during quality control.