Development of New Analytical Procedure for Some Drug Formulation in New Combined Dosage Forms

Abstract

The thesis describes the general introduction about UV-spectroscopy, HPLC, HPTLC, herbal formulation, analytical method development, evaluation of different validation parameters and impurity profiling study. It highlights the background of the present research work. An exhaustive literature survey was conducted to identify the drug combinations for the development of simultaneous UV-spectroscopy, RP-HPLC, HPTLC methods. Based on the literature survey the combinations selected were: Cefixime (CEF) and Ofloxacin (OFL), Melatonin (MEL) and Zolpidem (ZOL), Tranexamic acid (TRA) and Mefenamic acid (MEF), Thiocolchicoside (THI) and Ketoprofen (KET), Citicoline (CIT) and Piracetam (PIR). The Aim and objectives of the proposed research work, which are as follows: 1. To select the FDA approved multi drug combinations, bulk drug and herbal formulation. 2. To develop quantitative techniques for the selected multi drug combinations by developing a new UV spectroscopic method, High Performance Liquid Chromatographic method and High Performance Thin Layer Chromatographic method. 3. To develop an impunity profiling method for the estimation of the bulk drug and its formulation. 4. To validate the above developed analytical methods as per ICH guidelines. Thus to conclude, in the present research work, UV spectroscopic, RP-HPLC and HPTLC methods were developed for selected drug combinations/herbal combination and an impurity profiling method was developed for a bulk drug. All the developed methods were validated as per ICH guidelines. The methods were simple, accurate, precise and robust. These methods can be successfully used for the determination of selected drug combinations and herbal formulation in pharmaceutical dosage forms and they can also be applied in routine quality control tests. RP-HPLC and HPTLC methods are more reliable and efficient. The UV spectroscopic method has an advantage that, It may be used in all routine quality control tests wherein use of sophisticated instruments is generally not feasible.