DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF GLIPIZIDE AND MOMORDICININ IN RAT PLASMAAbstract
Momordicinin (MMR) is a major triterpenoid compound from Momordica charantia Linn fruit having antidiabetic potential, whereas glipizide (GPZ) is a well-known molecule in treatment of diabetes mellitus. The primary objective of the study is to develop and validate a simultaneous RP-HPLC method for upcoming pharmacokinetic studies to analyze herb-drug interactions. The study uses the protein precipitation method for plasma sample preparation. Chromatographic separation of GPZ and MMR was well achieved using hypersil gold C18 column (250 × 4.6, 5µm) and mobile phase constituting acetonitrile: phosphate buffer 10 mM with pH 3.5 (40:60, v/v). Quantification was done at wavelength 223 nm. The method was validated as per USFDA guidelines. The developed method showed good linearity over the range of 7-17 µg/ml, and the lower limit of quantifications was found to be 1.89 µg/ml and 1.99 µg/ml for MMR and GPZ, respectively. The extraction and chromatographic separation of both the drugs was found to be robust and reproducible. The %RSD for validation parameters was within the specified limits as per USFDA guidelines. The developed and validated bioanalytical RP-HPLC method for quantitative measurement of MMR and GPZ simultaneously was found to be accurate, rapid, simple, and reproducible, which will be applicable for future pharmacokinetic studies.
Akshay Ingle, Prajakta Kulkarni and L. Sathiyanarayanan *
Department of Pharmaceutical Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University) Pune, Maharashtra, India.
22 February 2021
13 May 2021
01 June 2021
01 January 2022