ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES FOR THE ESTIMATION OF NIMESULIDE AND DICYCLOMINE HYDROCHLORIDE IN FIXED DOSE COMBINATION TABLETSAbstract
A simple, accurate, and precise reversed-phase high-pressure liquid chromatography (RP-HPLC) method was developed for the simultaneous estimation of nimesulide and dicyclomine hydro-chloride in fixed-dose combination tablets. The developed method was validated as per ICH guidelines Q2(R1). The chromatographic separation was achieved on Hypersil ODS C18 (200 × 4.6 mm 5 μ) column using methanol: phosphate buffer (pH 4) 40:60 (v/v) as the mobile phase at a flow rate of 1 mL/min at 25 °C and detection at 215 nm. The retention times of nimesulide and dicyclominehydrochloride were 3.32 min and 4.22 min, respectively. The linearity range of nimesulide was 2.5-80 μg/mL, and that of dicyclominehydrochloride was 150- 650 μg/mL. The percent recovery of nimesulide and dicyclomine hydrochloride was found to be in the range of 98-102%. The developed method was validated as per ICH guidelines Q2 (R1) and can be used for the estimation of nimesulide and dicyclomine hydrochloride in fixed-dose combination tablets. The developed method can be extended to other dosage forms containing nimesulide and dicyclomine hydrochloride with slight modifications in sample preparation.
S. D. Cunha and T. Khan *
Department of Pharmaceutical Chemistry and Quality Assurance, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, Maharashtra India.
02 June 2020
07 May 2021
12 May 2021
01 June 2021