Author(s)
Raksha Patil, Mrs. Tai Yele
- ISSN (P): 3139-8464
- Manuscript ID: 140946
- Volume: 2
- Issue: 8
- Pages: 127–137
Subject Area: Other
Abstract
Proguanil hydrochloride and atovaquone represent a cornerstone fixed-dose combination therapy vital to global multi-drug-resistant Plasmodium falciparum malaria management. Due to the extreme divergence in their chemical polarities and asymmetric dose ratios (typically 100 mg to 250 mg), establishing unified quality control protocols presents unique analytical challenges. This comprehensive review synthesizes contemporary Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC), stability-indicating assays, and ultra-performance liquid chromatography (UPLC) methods engineered for their simultaneous estimation. We critically evaluate data across published parameters—comparing C18 versus C8 stationary phases, isocratic versus gradient elutions, mobile phase selections (utilizing volatile formate, acetate, or phosphate aqueous buffers paired with acetonitrile or methanol), and spectrophotometric uv wavelengths. Validation benchmarks matching ICH Q2(R1) specifications—specifically linearity, exact percentage recovery values, sensitivity metrics (LOD/LOQ), system suitability indicators, and robustness under stress—are systematically evaluated. Finally, the article highlights the industry's shift toward Green Analytical Chemistry (GAC), detailing techniques designed to maximize throughput while minimizing toxic solvent waste.