Pavan Kumar Jaini is an accomplished pharmaceutical industry professional with over 18 years of experience in formulation development, analytical method development and validation, pharmaceutical analysis, and regulatory compliance. He is currently associated with Ambio, Inc., USA, and has previously worked with KVK-Tech, Aizant Drug Research Solutions, and Hospira Health Care India Pvt. Ltd. His expertise includes injectable and oral dosage formulations, peptide-based pharmaceuticals, NDA/ANDA development, stability studies, Quality by Design (QbD), and USFDA and EU GMP regulatory requirements.

He holds an M.Pharm. in Industrial Pharmacy from Annamalai University and a B.Pharm. from Rajiv Gandhi University of Health Sciences. He is also a Ph.D. research scholar in Pharmaceutical Sciences at Raffles University, India. He has authored several pharmaceutical textbooks, published numerous research articles in peer-reviewed journals, contributed to patent development, and served as a reviewer for scientific journals. His professional interests focus on innovative drug formulation, analytical research, pharmaceutical quality assurance, and regulatory sciences.

Sustainable Quality by Design Approach Based UHPLC Technique for Triple Combination Antiviral Drugs: Appraisal of Green and White Metrics

The present research involves the quality by design (QbD)-facilitated development of a straightforward, rapid, sensitive, and economical ultra-high-performance liquid chromatographic method for the quantification of bictegravir, emtricitabine, and tenofovir alafenamide in a combined dosage form, alongside assessments of greenness, blueness, and whiteness. Systematic optimization was conducted using Box–Behnken design, selecting flow rate, buffer molarity, and ethanol volume as the critical method parameters (CMPs) identified from screening studies, thereby assessing the critical analytical attributes (CAAs), specifically retention time and resolution factors, as indicators of method robustness. The ideal chromatographic separation was accomplished utilizing ethanol and phosphate buffer (pH 3.0) at a ratio of 79.36:20.64 v/v as the mobile phase, with a flow rate of 0.27 mL/min and UV detection at 260 nm. The method was verified according to ICH guidelines, demonstrating a high degree of linearity, accuracy, precision, sensitivity, and robustness compared to existing liquid chromatographic methods for the drug. The environmental sustainability of the suggested approach was assessed utilizing the white analytical chemistry (WAC) framework and the Green Analytical Procedure Index (GAPI), and AGREE. The approach received good scores in both assessments, validating its negligible environmental impact and adherence to the principles of Green Analytical Chemistry. The method's practical applicability was demonstrated by the Blue Applicability Grade Index (BAGI). The technology was effectively implemented in formulation, demonstrating exceptional precision, accuracy, and recovery, while also being environmentally sustainable.