Development and Validation of Stability Indicating Derivative Spectrophotometric Methods for Determination of Duloxetine Hydrochloride
Journal Title: Journal of Pharmaceutical Research International - Year 2015, Vol 6, Issue 6
Abstract
Aim: The aim of the present investigation was to develop and validate a rapid, sensitive, cost effective and reproducible stability indicating derivative spectrophotometric method for the estimation of duloxetine HCl in bulk and in formulations. Methodology: First order derivative spectrophotometric methods were developed for duloxetine HCl employing peak-zero (P-0) and peak-peak (P-P) techniques and their stability indicating potential was assessed in force degraded solutions. The methods were validated with respect to linearity, accuracy, precision and robustness. Results: Linearity was observed in the concentration range 5 μg/mL-90 μg/mL with an excellent correlation coefficient (r2) of 0.999. The limits of assay detection values were found to range from 0.33-0.41 μg/mL and quantitation limits ranged from 1.01-1.24 μg/mL for the proposed methods. The proposed method was applicable to the determination of the drug in capsules and the percentage recovery was found to be 99.68±0.95%. Conclusion: The developed methods were successfully validated and applied to the determination of duloxetine HCl in bulk and pharmaceutical formulations without any interference from common excipients. Satisfactory recovery in force degraded solutions suggests the stability indicating nature of the assay.
Authors and Affiliations
Renu Chadha, Alka Bali
Pharmacokinetics of Nevirapine in HIV Infected Children from Resource Limited Settings Using Fixed Dose Anti-retroviral Combinations
Introduction: The pharmacokinetics of nevirapine in paediatric populations are important to consider for those receiving anti-retroviral treatment in resource limited settings. High rate of adherence is required to achie...
Simultaneous Estimation of Luteolin and Apigenin in Methanol Leaf Extract of Bacopa monnieri Linn by HPLC
Aims: To develop, validate and quantify the content of flavonoids luteolin and apigenin in aerial parts of methanol leaf extract of Bacopa monnieri (B. monnieri) by reverse phase liquid chromatography. Study Design: High...
Evaluation of Anti-diabetic Potentials of Methanol Extract of Ficus hispida Linn. Leaves Against Alloxan Induced Diabetic Rats
Objective: The present study was designed to evaluate the acute and chronic effects of the methanol extract of Ficus hispida against alloxan (150 mg/kg) induced diabetic rats. Methods: In acute study, hypoglycemic poten...
Preparation and Characterization of Polymeric Mucoadhesive Film for Buccal Administration
Objectives: Buccal films consist mainly of polymer that has a good mucoadhesive profile and plasticizer. A lot of polymers and plasticizers can be used to configure the mucoadhesive films as hydroxyethyl cellulose and gl...
Lipid Charecterization and Fatty Acid Profiles of Clarius batrachus and Its Defense Activity
Innate Defense Components were being useful to identify and understand their mode of action on microbial pathogens. The present study portrays the qualitative and quantitative determination of endogenous lipids from the...