Development of Assay Methods for Fixed Dose Combinations

The development of fixed-dose combinations (FDCs) is increasingly high, either improving compliance or benefiting from the added effects of the two or more active drugs given together. They are being used to treat a wide range of conditions and are particularly useful in managing chronic diseases. FDC drugs have been used for some time in specific therapeutic categories such as anti-hypertensive, anti-retroviral, anti-lipidomic, hypoglycemic drugs, etc. With the revolution in the survival rates of patients suffering from human immune deficiency virus (HIV) infection that occurred with the implementation of fixed drug combination products for this indication, this delivery technology received a boost of confidence and an influx of creative applications to other diseases.

Hence, it becomes necessary to develop new or modified analytical methods for combination products under the above circumstances.

Hence, the author inspired to contribute to society with an intention and aiding to control the product's quality whereby the right product must reach the customer. The author has selected a few combinations of anti-hypertensive, anti-lipidomic, antiretroviral, and hypoglycemic drugs to demonstrate the development and validation of simple, precise, and susceptible analytical methods.

This book covers method development and validation for eight new HPLC analytical methods for combination products. QC laboratories can use these methods to ensure the purity of drugs in combined pharmaceutical dosage forms.

This book explores the research work performed and focused on the Development of New RP-HPLC methods for the Quantification of the drug in the marketed dosage forms. The book also includes the validation and application on Tablets of the developed method as per ICH requirements