Method Development for the Simultaneous Estimation of Prazosin and Polythiazide by UPLC Using QbD Approach

Introduction

Prazosin is a quinazoline derivative and a selective antagonist of the α1 adrenergic receptor. The atomic structure is C₁₉H₂₁N₅O₄ and its molecular weight is 383.41 Prazosin is a helpful medication for managing and treating various illnesses. Through the thiazide-sensitive Na-Cl co-transporter, at the early distal tubule the diuretic polythiazide prevents active chloride re-absorption, increasing the excretion of water, salt and chloride. Its molecular formula is C₁₁H₁₃ClF₃N₃O₄S₃.

Materials and Methods

The chromatographic settings were optimized using Design Expert Software. Column used is DIKMA spursil Column C18 (2.1x50 mm; 3.0 micrometre), ratio of the mobile phase KH₂PO₄: Methanol (45:55), pH 3 phosphate buffer.

Results

The flow rate 0.3 mL/min. Run time: 5 min, wavelength: 265 nm, injection volume: 4 μL. For polythiazide and prazosin, the % RSD of precision was found to be 0.8 and 0.2, respectively. Polythiazide and Prazosin had accuracy of 100.15 and 100.30, linearity COR is 0.999 for both drugs, the corresponding LOD and LOQ were determined to be 2.91 and 10.04, accordingly. The percentages of Studies on acid, base, peroxide, thermal and photodegradation revealed that 0.27, 3.93, 10.66, 7.36 and 7.07.

Conclusion

The UPLC-QbD validated method is used to determine the amounts of Polythiazide and Prazosin. This approach assessed the system's suitability, specificity, sensitivity, accuracy, linearity, precision and robustness according to ICH standards.