Abstract

NEW BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NAPROXEN BY LCMS

Salomi. P*, Mallesh Mandha and M. Purushothaman

ABSTRACT

Bio analysis employed for the quantitative determination of drugs and their metabolites in biological fluids. Studies involving measurement of the drugs or metabolites in the biological fluids such as blood plasma, serum, urine, CSF, etc. requires the selective, sensitive, well characterized bio analytical method to yield reliable results which can be satisfactorily interpreted as well as to emphasize that each analytical technique has its own characteristics, which will vary from analyte to analyte. A research was carried out to develop and validate bioanalytical method by high performance liquid chromatography mass spectrometric method for the estimation of Naproxen in human plasma using Zidovudine as internal standard. The method was validated over a concentration range of 500.1 ng/mL to 100028.5 ng/mL for Naproxen. The results of selectivity, carryover test, linearity, precision and accuracy, stabilities, recovery, and Concomitant Drug Effect presented in this report are within the acceptance range for bio-analytical batch acceptance criteria given in USFDA acceptance range as per „Guidance for Industry – Bio-analytical Method Validation. The analytical method described above is valid for the estimation of Naproxen in human plasma over a range of 500.1 ng/mL to 100028.5 ng/mL with the detection of Naproxen m/z – 229.00 (parent) and 185.00 (product) and internal standard Zidovudine m/z – 267.00 (parent) and 222.90 (product) in negative ion mode, it is concluded that the analytical method developed was novel, accurate, précised selective and is suitable for application in routine analysis of pharmaceutical preparation and is with in acceptance range for bio-analytical criteria in USFDA acceptance.

Keywords: Naproxen, LCMS, Bio-Analytical Method.