Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Olmesartan Medoxomil and Metoprolol Succinate in Pharmaceutical Dosage Form.

Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in pharmaceutical dosage form.

Pharm Methods. 2012 Jul; 3(2): 84-9
Thakker NM, Panchal HB, Rakholiya DR, Murugan R, Choudhari VP, Kuchekar BS

AIM AND BACKRGOUND: A simple, rapid, precise and isocratic RP-HPLC (Reverse Phase High Performance Liquid Chromatography) method is aimed to develop for the simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in bulk drug and pharmaceutical dosage form.The quantification is carried out using YMC-Pack CN (250 × 4.6 mm, 5.0 ?m) column and the mobile phase comprises of 0.05% Trifluoro acetic acid (TFA) and Acetonitrile (ACN) (70:30 v/v). The flow rate is 1.0 ml/min. The eluent is monitored at 220 nm. The retention times of Olmesartan Medoxomil and Metoprolol Succinate are 7.9 min and 4.1 min respectively. The method is validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation.Linearity and percentage recoveries of both Olmesartan Medoxomil and Metoprolol Succinate are in the range of 5-35 ?g/ml and 100 ± 2%, respectively. The stress testing of both the drugs individually and their mixture is carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation (dry heat and wet heat) conditions and its degradation products are well resolved from the analyte peaks.This method was successfully validated for accuracy, precision, and linearity. HubMed – drug


Comparison of UV spectrophotometry and high performance liquid chromatography methods for the determination of repaglinide in tablets.

Pharm Methods. 2012 Jul; 3(2): 68-72
Dhole SM, Khedekar PB, Amnerkar ND

Repaglinide is a miglitinide class of antidiabetic drug used for the treatment of type 2 diabetes mellitus. A fast and reliable method for the determination of repaglinide was highly desirable to support formulation screening and quality control.UV spectrophotometric and reversed-phase high performance liquid chromatography (RP-HPLC) methods were developed for determination of repaglinide in the tablet dosage form.The UV spectrum recorded between 200 400 nm using methanol as solvent and the wavelength 241 nm was selected for the determination of repaglinide. RP-HPLC analysis was carried out using Agilent TC-C18 (2) column and mobile phase composed of methanol and water (80:20 v/v, pH adjusted to 3.5 with orthophosphoric acid) at a flow rate of 1.0 ml/min. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the International Conference on Harmonization (ICH) guidelines.The developed methods illustrated excellent linearity (r(2) > 0.999) in the concentration range of 5-30 ?g/ml and 5-50 ?g/ml for UV spectrophotometric and HPLC methods, respectively. Precision (%R.S.D < 1.50) and mean recoveries were found in the range of 99.63-100.45% for UV spectrophotometric method and 99.71-100.25% for HPLC method which shows accuracy of the methods.The developed methods were found to be reliable, simple, fast, accurate and successfully used for the quality control of repaglinide as a bulk drug and in pharmaceutical formulations. HubMed – drug


Estimation of sertraline by chromatographic (HPLC-UV273 nm) technique under hydrolytic stress conditions.

Pharm Methods. 2012 Jul; 3(2): 62-7
Rahman MA, Iqbal Z, Mirza MA, Hussain A

In this paper, simple, specific and accurate RP-HPLC method was developed in order to study decomposition of sertraline (SRT) under the hydrolytic stress conditions (acid, neutral, alkaline and oxidative).The best separation of SRT and its degradation products were achieved on reverse phase LiChoCART with Purospher (RP-18e) column. The mobile phase was composed of methanol/water (75:25, v/v). The detection wavelength was 273 nm. The method was validated and response was found to be linear in the drug concentration range of 10-200 ?g ml-1 with correlation coefficient of 0.998.The RSD values for intra- and inter-day precision were < 0.65 and < 0.72%, respectively. Employing RP-HPLC method, degradation products were detected in the exposed samples.IT WAS FOUND THAT THE SUSCEPTIBILITY OF SRT TO HYDROLYTIC DECOMPOSITION INCREASED IN FOLLOWING MANNER: Neutral condition < alkaline condition < acid condition < oxidative condition. HubMed – drug