DEVELOPMENT AND VALIDATION OF CARBAMAZEPINE PLASMA CONCENTRATIONS MEASUREMENT AND ITS APPLICATION ON EPILEPSY PATIENTS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2017, Vol 9, Issue 9
Abstract
Objective: To develop and validate high-performance liquid chromatography with photodiode array (HPLC-PDA) detector as a method for measuring carbamazepine plasma concentrations in epilepsy patients treated with monotherapy or polytherapy.Methods: Carbamazepine was extracted from epilepsy patients’ plasma through liquid-liquid extraction, using protein precipitation with chloroform. Analysis was performed using HPLC with Inertsil DS-4 C18 (4.6x150 mm), 5 μm particle size column. The optimal condition for separation was established in a mobile phase consisting of acetonitrile: water (50:50) at a flow rate of 1.0 ml/min, detected by PDA detector at 220 nm. Propylparaben was used as the internal standard. The retention time was 3.5 min.Results: Linearity was obtained over a concentration range of 0.5-16 μg/ml with r = 0.999. The method showed good intra-and inter-day precision and accuracy of more than 90% difference (% diff) and 95% relative standard deviation (RSD). Lower limit of quantification (LOQ) was 0.5 μg/ml and lower limit of detection (LOD) was 0.2 μg/ml with 100% accuracy and more than 90% precision. Recovery test was nearly 100%. Stability of carbamazepine plasma concentration in 3 epilepsy patients was measured on the first and third month of treatment, ranging between 83.5 to 98.7%. When used to compare carbamazepine as a monotherapy versus polytherapy, the method showed good selectivity.Conclusion: The present HPLC method was valid for measuring carbamazepine plasma concentrations in epilepsy patients treated with monotherapy or polytherapy. This method meets the standard in the EMEA guideline in terms of linearity, precision, and accuracy, also selectivity in epilepsy patients treated with polytherapy.
Authors and Affiliations
Astri Budikayanti, Chiswyta Chaliana, Melva Louisa, Rianto Setiabudy
Keywords
Related Articles
- EP ID EP575498
- DOI 10.22159/ijpps.2017v9i9.19402
- Views 74
- Downloads 0
IMMUNOMODULATORY, ANTICANCEROUS & ANTIOXIDANTACTIVITIES OF CYCLEA PELTATA (LAM.) HOOK.F. & THOMSON
Introduction: Cyclea peltata (Lam.) Hook.f. & Thomson is an important plant listed in Ayurveda. The plants are used in digestive, diuretic and inflammatory disorders. Aim: The present study was to study the immunomo...
FORMULATION OF KETOCONAZOLE LOADED NANO DISPERSIVE GEL USING SWOLLEN MICELLES TECHNIQUE AND ITS IN VITRO CHARACTERIZATION
Objective: The objective of the present work was to formulate and characterize nano dispersive gel (NDG) for topical delivery of water-insoluble antifungal agent ketoconazole in order to enhance its solubility, penetrati...
PROTECTIVE EFFECT OF ETHANOL EXTRACT OF CENTAUREA BEHEN LINN IN CARBON TETRA CHLORIDE-INDUCED HEPATITIS IN RATS
Objectives: To evaluate the hepatoprotective activity of Ethanolic extract of root of Centaurea behen Linn were studied against Wister rats with liver damage induced by carbon tetrachloride (CCl4)Methods: Â The hepatopro...
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TAPENTADOL HCL, ACECLOFENAC AND PARACETAMOL IN TERNARY MIXTURE
Objective: To develop a accurate, precise and specific RP-HPLC method for simultaneous estimation of Tapentadol HCl (TAP), Aceclofenac (ACE) and Paracetamol (PCM) in its laboratory synthetic mixture.Methods: The optimize...
EFFICACY OF UNANI FORMULATIONS IN CHRONIC ENDOCERVICITIS: A RANDOMIZED COMPARATIVE STUDY
Objective: To compare the efficacy of Unani formulation in chronic endocervicitis.Methods: A parallel, comparative randomized trial was conducted at Govt. Nizamia General Hospital, Hyderabad from 1998 to 2000 in 50 patie...