STABILITY INDICATING SPECTROPHOTOMETRIC METHODS OF NELFINAVIR AND THEIR APPLICATION TO IN-VITRO BIOEQUIVALENCE TESTING

Abstract

Author(s): Fathi H Assaleh, Shanta Kumari Adiki, Shaban G Elosta, Fathi M Asseid, Prakash Katakam* and Babu Rao Chandu

The present investigation was aimed at developing the stability indicating spectrophotometric methods for the determination of nelfinavir mesylate (NEM) in pharmaceutical dosage forms. The stability of NEM was tested in various dissolution media maintained at ambient temperature and 37oC for 48 h. Stability studies of NEM in various media indicated that the drug was stable in 0.1M HCl and pH 7.8 phosphate buffer. The λmax were found 201.4 and 212.0 nm for 0.1M HCl and pH 7.8 phosphate buffers respectively with low coefficient of variation of < 5.11 %. The linearity of NEM was found in the range of 0.5 - 60 µg/mL for 0.1M HCl and 0.5 - 40 µg/mL for pH 7.8 phosphate buffer. The validated methods were applied to determine NEM concentration in formulations. In-vitro dissolution testing indicated that the NEM was stable and drug release was uniform from tablet dosage forms. The optimized media could be employed to study the dissolution profiles of NEM in bioequivalence studies.