Development and Validation of Analytical Methods for Quantification of Some Novel Drugs in Formulation

Abstract

In present study simultaneous equation in UV methods, RP- HPLC and HPTLC were developed and validated for some of the selected formulations containing two drug combinations. UV spectroscopic methods solving simultaneous equation is developed and validated for the following drug combination and formulation: (i) Naproxen and Esomeprazole magnesium, (ii) Temisartan and Cilinidipine, (iii) Cilastatin sodium and Imipenem, (iv) Propranolol hydrochloride and Alprazolam. In UV spectroscopy all the selected raw materials were dissolved in methanol and their spectra were recorded and the formulations were analysed. The actual amount of drugs in formulation was calculated by solving simultaneous equation. As the methods require only methanol as a solvent and less time consuming process, it can be followed in routine analysis to standardize the raw material as well as finished products with reproducible results. In RP-HPLC mobile phase and stationary phase played an important role in the resolution of the drugs. Chromatographic conditions were optimized before the development of chromatogram. Then the system suitability parameters were calculated. The formulations selected were then analyzed using fixed chromatographic parameters. The data obtained were subjected to statistical analysis. The developed RP-HPLC methods were validated for specificity, repeatability, reproducibility, linearity, robustness, stability of solution and system suitability as per ICH guidelines. As the methods are accurate, reproducible and highly sensitive at microgram levels of analyte it can be conveniently used in drug control laboratories and in industries to estimate the drug content in raw materials as well as in finished products. It was concluded that all UV spectrophotometric, RP-HPLC and HPTLC methods were found to be accurate, economic and rapid. Hence, the developed methods could be conveniently adopted for the routine analysis in formulations and for analyzing raw materials. newline newline