A VALIDATED SIMULTANEOUS HPLC METHOD FOR DETERMINATION OF ASSAY OF TEMAZEPAM AND FORCED DEGRADATION STUDIES
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 11
Abstract
A new HPLC method was developed for selective and simultaneous determination of of Teamazepam. The developed method is also applicable for the related substances determination in bulk drugs. The chromatographic separation was achieved on a Zorbax SB C-18, 4.6 x 250mm, and 5µ column. The mobile phase consisted of Acetonitrile and methanol (60:40, v/v) delivered at a flow rate of 2.0 mL min−1. Buffers consisted of dissolve 5.22 g of dipotassium hydrogen orthophosphate in 1000 mL of water and add 2 mL of triethylamine, adjust pH to 3.0 with ortho phosphoric acid. The mobile phase was pumped at a flow rate 2.0 mL per minute and detector of UV at 245 nm. In the developed HPLC method, the resolution between Teamazepam and its potential impurities, namely Imp-A, Imp-B, Imp-C, and Imp-G was found. Accuracy found by % recovery from 99.2-100.5 at 80.0% to 120.0% level and the linearity results for Teamazepam and its related compounds in the specified concentration calibration curves linear with coefficient of variation (r) not less than 0.99 The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur acid hydrolysis conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 95% - 105%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness. The validation was performed according to the current requirements as laid down in the ICH guidelines.
Authors and Affiliations
B. Satyanarayana, P. Krishna, D. Ramachndran
Keywords
Related Articles
- EP ID EP98243
- DOI -
- Views 111
- Downloads 0
COMPARATIVE STUDY OF ORAL L-ARGININE THERAPY VERSUS NON-AMBULATORY TREATMENT IN PREGNANCY WITH ASYMMETRICAL FETAL GROWTH RESTRICTION
L-arginine is a unique molecule that produces nitric oxide in body and plays a crucial role in physiological hemodynamic modification in pregnancy. A randomised comparative prospective study was carried out in a maternit...
PHYSICIANS' KNOWLEDGE, ATTITUDES AND PRACTICE ABOUT THE TREATMENT OF HIGH BLOOD PRESSURE ACCORDING TO THE SEVENTH REPORT OF THE JOINT NATIONAL COMMITTEE (JNC VII)
Hypertension is one of the most frequently encountered chronic medical conditions in almost all societies. The Seventh Report of the Joint National Committee (JNC-7), published in 2003 is an important tool on Detection,...
POTENTIAL CELL LINE TOXICITY OF ENVIRONMENTAL NANOPARTICLES
In India, the unprecedented growth rate and urbanization along with the rapid increase in motor vehicle activity and industrialization are contributing to high levels of urban air pollution. The population is mainly expo...
FORMULATION AND EVALUATION OF SUSTAINED RELEASE PELLETS OF TRAMADOL HYDROCHLORIDE
The aim of the present research is to develop and evaluate a better sustained release multiple unit pellets (MUP) formulation of Tramadol hydrochloride. Dissolution and diffusion controlled systems have classically been...
A REVIEW ON PULSATILE DRUG DELIVERY SYSTEM
Pulsatile Drug Delivery Systems are gaining a lot of interest as they deliver the drug at the right place at the right time and in the right amount, thus providing spatial and temporal delivery and increasing patient com...