NEVIRAPINE RESIDUE ANALYTICAL METHOD OPTIMIZATION FOR PRODUCTION MACHINES CLEANING VALIDATION AT ANTI RETROVIRAL DIVISION OF PT. KIMIA FARMA PLANT JAKARTA

• Main Author: Widyawan, Irving
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/79000
• Institution: Institut Teknologi Bandung

As regulatory fulfillment related to effectiveness confirmation of machines cleaning procedure at PT. Kimia Farma Plant Jakarta Anti Retroviral (ARV) division, optimization and analytical method validation for ARV product residue had been done. Marker study had been conducted resultirfg Nevirapine as selected marker with 0.6109 mg/cm2 Maximum Allowable Carry Over (MACO). Nevirapine residue analytical methods by High Performance Liquid Chromatography (HPLC) was developed by applying Quality by Design (QbD) concept and quality risk assessment. The optimum chromatographic conditions are obtained using C 18 column (3.9 x 150 mm; with 10.0 urn particle size); flow rate at 0.95 ml / min.; isocratic mobile phase combination of acetonitrile and water (23: 77); detection using UV detector at a wavelength of 214 nm. The method operational limit range has been verified for flow rate of 0.92 ml / min to 0.98 ml / min; volume injection of 30 PI; and a combination of ethanol and water with a percentage of 51.5 : 48.5. Nevirapine peak had been well separated, with 0.227 pg / ml limit of quantitation. Analytical methods had been validated in the range 10% to 190% of MACO value.