DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD OF NEPAFENAC AND ITS DEGRADATION PRODUCTS: APPLICATION TO DEGRADATION KINETIC
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2014, Vol 6, Issue 9
Abstract
Objective: The objective of present work was to develop and validate simple, precise, accurate and specific stability indicating method for determination of nepafenac in presence of its degradation products and application of the method to study degradation kinetics.Methods: A novel isocratic RP-HPLC method has been developed using C8Olyster column, (250X4.6 mm i. d, 5m particle size) with the mobile phase composition of ACN: 10 mM Ammonium formate buffer (pH 4.0): Methanol (27.5:45:27.5). The flow rate was at 1.0 ml min-1 and effluent was detected at 238 nm. Nepafeac was subjected to stress degradation under acid, base, neutral hydrolysis, oxidation, dry heat, humidity and photolysis, conditions. Kinetic study was also performed.Results: The degradants peaks were well resolved from Nepafenac peak. Significant degradation was observed in acid, base and oxidative degradation. The drug is relatively stable towards photolysis and dry heat.Conclusion: Stability of Nepafenac was determined by stability indicating assay method. Three degradation related impurities was identified by LC-MS. The hydrolytic degradation pathway of nepafenac was postulated. The developed stability indicating method was applied to determine acid, base and oxidative degradation kinetic. Acid hydrolysis and oxidative degradation followed zero order while base hydrolysis followed first order kinetic. Degradation rate constants and half-life were determined.Â
Authors and Affiliations
Chhaya Shrimali, Madhuri Baghel, Sadhana J Rajput
3-AMINOBENZAMIDE, A POLY (ADP-RIBOSE) POLYMERASE INHIBITOR, RESTORES BIOENERGETICS BUT FAILS TO ALLEVIATE EXCITOTOXICITY AND MOTOR FUNCTIONS IN 3-NITROPROPIONIC ACID INTOXICATED MICE
Objective: The present study was undertaken to investigate the effects of 3-aminobenzamide (3-AB), a poly (ADP-ribose) polymerase 1 (PARP1) inhibitor, on motor functions along with brain excito toxicity and bioenergetics...
IN VITRO ANTHELMINTIC EFFECTS OF SENNA OCCIDENTALIS (L.) LINK (LEGUMINOSAE) ON RAT TAPEWORM HYMENOLEPIS DIMINUTA
Objective: This study was conducted to evaluate the anthelmintic activity of ethanolic leaf extract of Senna occidentalis on rat tapeworm Hymenolepis diminuta.Methods: Adult H. diminuta worms were obtained from laborator...
Perceptions of patients’ care givers regarding clinical pharmacists and their practice in a developing countryPERCEPTIONS OF PATIENTS’ CARE GIVERS REGARDING CLINICAL PHARMACISTS AND THEIR PRACTICE IN A DEVELOPING COUNTRY
Objective: The aim of the study was to report the perception of the care givers of the patients who have come across clinical pharmacists in their treatment course in a developing country like Pakistan.Methods: A cross s...
ACUTE AND SUB-ACUTE ORAL TOXICITY ASSESSMENT OF THE POLYHERBAL FORMULATION IN ALBINO WISTER RATS
Objective: Polyherbal formulation (PHF) is prepared from five herbs; these herbs are well-known and widely used in the traditional system of medicine for the treatment of diabetes and various diseases. Individually, each...
I-STAT, COAGUCHEK XS PLUS, AND HEMOCHRON VERSUS REFERENCE LABORATORY INRS: PHARMACIST-MANAGED CLINICS
Objectives: The international normalized ratio (INR) is the primary measure used to determine the therapeutic effect of warfarin. I-Stat, CoaguChek-XS Plus, and Hemochron are the most frequently used point-of-care tests...