Microwave-assisted heating: innovative use in hydrolytic forced degradation of selected drugs

ABSTRACT

Stress testing has been executed to illuminate the inherent stability characteristics of drug substances and drug products. As an alternative to the conventional hydrolytic forced degradation, which is carried out at the elevated temperature for an elongated time period, microwave-assisted heating is believed to be more promising. The later technique offers many advantages over conventional heating technique like fast, efficient heat source, a more reproducible result due to the control of parameters, eco-friendly, unlike conventional heating source, it heats up only the molecules which absorb microwave energy and not the apparatus first. Present work reports microwave-assisted hydrolytic degradation studies of selected drugs, namely Lurasidone, Risperidone, Paliperidone, Alprazolam, Escitalopram, Atomoxetine, Repaglinide, Furosemide, Hydrochlorothiazide and Olmesartan. The degradation samples were analysed by using high-performance liquid chromatography techniques. The degradation products generated by conventional and microwave heating methods were compared with respect to relative retention time. Though selected drugs have different chemical structures, the unaltered degradation profile was observed when conventional heating was replaced by microwave heating. With the proposed microwave heating technique, degradation products were generated in drastically lesser time from many hours to minutes without generation of secondary degradation products.

KEYWORDS:

• Forced degradation study
• conventional heating
• microwave heating
• drug substances
• degradation profile

Acknowledgement

The authors are obligated to Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India, for providing the support and encouragement to carry out present work which is a part of Doctor of Philosophy (PhD) research work of Prutha Patel, to be submitted to Nirma University, Ahmedabad, India.

Disclosure statement

The authors declare that they have no conflict of interest. This article does not contain any studies with human participants or animals performed by any of the authors.

Additional information

Notes on contributors

Prutha Patel

Prutha Patel was born in Gujarat, India, in 1990. She has completed B.Pharm from A.R. College of Pharmacy, V.V. Nagar, Gujarat, India and M.Pharm in pharmaceutical analysis from K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India in 2013. She is now a PhD research scholar at Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India. Her main research interests are microwave energy applied to degradation studies such as hydrolytic forced degradation, thermal stress testing, and accelerated stability testing of pharmaceuticals.

Priti Mehta

Dr Priti Mehta has completed her M.Pharm in quality assurance from L.M. College of Pharmacy, Ahmedabad, Gujarat, India and PhD from Gujarat University, Ahmedabad, Gujarat, India. Dr Mehta has 17 years of teaching and industrial experience. She has published number of research papers and review articles in Indian & International Journals. She is a recipient of M.L. Khorana award for the best research paper in pharmaceutical analysis published in 2004. She is also recipient of P.D. Sethi award and R.V. Patel Best thesis award in guide category. She has presented research paper in International conference at USA. Dr. Mehta has delivered guest lectures at various Institutions during seminars, workshops and staff development program. She received financial support from various government bodies like DBT, GUJCOST to organize workshop, symposium etc. She has rendered professional services to leading Universities at various capacities. Her research areas of interest are stability studies, impurity profiling, elucidation of degradation pathways of drugs, isolation and characterization of active moiety from plants and bioequivalence and bioavailability studies. She is a recognized postgraduate and PhD guide at Nirma University, Ahmedabad, Gujarat, India.