scholarly journals Validation of a dissolution method with RP-HPLC analysis for Perindopril erbumine and Indapamide combination tablet

2012 ◽  
Vol 18 (1) ◽  
pp. 19-25 ◽  
Author(s):  
P.S. Jain ◽  
P.R. Badreshiya ◽  
S.S. Chalikwar ◽  
A.A. Todarwal ◽  
S.J. Surana
Keyword(s):  
High Performance ◽  
Hplc Analysis ◽  
Solution Stability ◽  
Uv Detector ◽  
Combination Tablet ◽  
Dissolution Method ◽  
Perindopril Erbumine ◽  
Tablet Formulations ◽  
Usp Apparatus ◽  
Regulatory Filing

A Dissolution method with high performance liquid chromatography (HPLC) analysis was validated for perindopril erbumine and indapamide in combination tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, linearity, accuracy, precision, range, robustness and solution stability studies. The dissolution method, which uses USP apparatus 1 with basket rotating at 100 rpm, 1000 ml of phosphate buffer pH 6.8 as the dissolution medium, and reversed-phased HPLC was carried out at 50?C on a 4.6mm?250mm 5?m cyano column that contained USP packing L1 with acetonitrile: buffer pH 2.8::40:60 (v/v), as mobile phase. UV detector was set at 225 nm. A method was found to be selective, linear, accurate and precise in the specified ranges. Intra-day and inter-day variability for method was <2% RSD. This method was successfully used for quantification of perindopril erbumine and indapamide combination tablet formulations.

Optimum HPLC Conditions for Determination of Dibucaine HCL, Fluocortolone Pivalate and Fluocortolone Caproate by Using Experimental Design

2018 ◽  
Vol 15 (1) ◽  
pp. 32-38 ◽  
Author(s):  
Bürge Aşçı ◽  
Mesut Koç
Keyword(s):  
Experimental Design ◽  
Flow Rate ◽  
Mobile Phase ◽  
High Performance ◽  
Limit Of Detection ◽  
Pharmaceutical Preparations ◽  
Acid Mixture ◽  
Solution Stability ◽  
Uv Detector

Introduction:This paper presents the development and validation of a novel, fast, sensitive and accurate high performance liquid chromatography (HPLC) method for the simultaneous quantitative determination of dibucaine HCl, fluocortolone pivalate and fluocortolone caproate in pharmaceutical preparations.Experiment:Development of the chromatographic method was based on an experimental design approach. A five-level-three-factor central composite design requiring 20 experiments in this optimization study was performed in order to evaluate the effects of three independent variances including mobile phase ratio, flow rate and amount of acid in the mobile phase.Conclusion:The optimum composition for mobile phase was found as a methanol:water:acetic acid mixture at 71.6 : 26.4 : 2 (v/v/v) ratio and optimum separation was acquired by isocratic elution with a flow rate of 1.3 mL/min. The analytes were detected using a UV detector at 240 nm. The developed method was validated in terms of linearity, precision, accuracy, limit of detection/quantitation and solution stability and successfully applied to the determination of dibucaine HCl, fluocortolone pivalate and fluocortolone caproate in pharmaceutical topical formulations such as suppositories and ointments.

scholarly journals Detection Of Pendimethalin and Cypermetrin Residues in Locally Produced Tomato Using QuEChERS-HPLC Analysis

2020 ◽  
Vol 27 (1) ◽  
pp. 34-40
Author(s):  
L.B. Abdulra’uf ◽  
F.A. Adeyemo ◽  
F.B. Atanda ◽  
R. Lawal
Keyword(s):  
Chromatographic Analysis ◽  
High Performance ◽  
Hplc Analysis ◽  
Correlation Coefficients ◽  
Ultra Violet ◽  
Uv Detector ◽  
Relative Standard ◽  
Detector Method ◽  
Maximum Residue Levels ◽  
Residue Levels

This study investigated the levels of pendimethalin and cypermetrin residues in tomato sold in Malete market, Moro Local Government Area of Kwara State. Tomatoes were randomly collected from five different vendors in Malete market and analysis was performed using the QuEChERS (Quick, Easy Cheap, Effective, Rugged and Safe) method followed by chromatographic analysis using high performance liquid chromatography (HPLC) coupled to ultra-violet (UV) detector. Method validation of the study showed a linearity of the analytes which ranges from 5 – 500 μg/kg, with correlation coefficients greater than 0.999. The average recovery ranges from 75.6 to 111 % with relative standard deviation (RSD) from 2.74 to 9.03 %. The results indicated the presence of cypermethrin in analyzed samples at concentrations lower than the permissible maximum residue levels Keywords: Sample preparation, Pesticide residues, HPLC-UV, QuEChERS.

Development and Validation of a Pre-Column Derivatization HPLC Method for the Assay of Amikacin Sulfate in Pure and Parenteral Dos age Forms

2019 ◽  
Vol 15 (5) ◽  
pp. 511-520 ◽  
Author(s):  
Muneeba Usmani ◽  
Sofia Ahmed ◽  
Muhammad Ali Sheraz ◽  
Iqbal Ahmad
Keyword(s):  
High Performance ◽  
Reference Method ◽  
Hplc Method ◽  
Test Method ◽  
Base Hydrolysis ◽  
Solution Stability ◽  
Uv Detector ◽  
Stress Degradation ◽  
Degradation Studies ◽  
Amikacin Sulfate

Background: Amikacin sulfate (AMK) belongs to the class of aminoglycoside antibiotics. It is effective against the infections caused by Gram-negative and positive bacteria. AMK lacks a chromophore group in its structure and, therefore, it does not absorb light in the 200-800 nm region which makes it a difficult molecule to analyze by UV detector using high performance liquid chromatography (HPLC). Objective: This study has been carried out to develop and validate a relatively simple, accurate, precise, rapid, economical, and stability-indicating pre-column derivatization HPLC method for the determination of AMK in pure and parenteral dosage forms. Methods: The stock solution of AMK was derivatized prior to its analysis. The mobile phase used for the analysis was acetonitrile and water in the ratio of 50:50 (v/v) at pH 6.0. The method has been validated according to the guideline of International Council for Harmonization (ICH) and different parameters such as linearity, range, accuracy, precision, sensitivity, robustness, solution stability, specificity and system suitability have been studied. AMK was subjected to stress degradation studies including thermolysis, humidity exposure, acid-base hydrolysis, and oxidation in order to determine the specificity of the test method. Results: The retention time of AMK has been found to be 4.7 min. The results indicated that the method is linear in the concentration range of 12.5-125% and possesses high accuracy (99.88±0.42%), precision ((<1.2%) and robustness (<0.5%). The obtained results are compared statistically with a reference method. Conclusion: It was observed that the stress degradation studies do not affect the accuracy of the method. Hence the proposed method can be used for the assay of AMK and its parenteral dosage form.

Simultaneous HPLC Method Development and Validation of Bilastine and Montelukast in Bulk and Formulation

2021 ◽  
pp. 6061-6065
Author(s):  
Ankita Shinde ◽  
G.B. Gajeli ◽  
Sneha Ubale ◽  
Vinod Matole
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Tablet Formulations ◽  
Hplc Method Development ◽  
Development And Validation

A new, simple, rapid, selective, precise and accurate reverse phase high performance liquid chromatography assay has been developed for simultaneous estimation of Bilastine, and Montelukast in tablet formulations. The separation was achieved by using Phenomenax Kinetex XB C-18 column (150 x 4.6mm, 5 .) using mobile phase Methanol: 0.1% TFA water (80:20). Injection volume was 10µl. The flow rate was 1.0mL.min-1 and the separated drugs were detected using UV detector at the wavelength of 270nm. The retention time of Bilastine and Montelukast was noted to be 1.27, and 4.86 respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations containing any one of the above drugs, or a combination, without any alteration in the chromatographic conditions.

Development and Validation of A Reversed Phase-High Performance Liquid Chromatography Method for the Quantitative Estimation of Ramipril Drug Content from Formulated Dosage Form

2016 ◽  
Vol 6 (3) ◽  
Author(s):  
Raju Chandra ◽  
Manisha Pant ◽  
Harchan Singh ◽  
Deepak Kumar ◽  
Ashwani Sanghi
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Active Ingredient ◽  
High Performance ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Reversed Phase ◽  
Uv Detector ◽  
Chromatography Method ◽  
Drug Content

A reliable and reproducible reversed-phase high performance liquid chromatography (RP-HPLC) was developed for the quantitative determination of Remipril drug content from marketed bulk tablets. The active ingredient of Remipril separation achieved with C18 column using the methanol water mobile phase in the ratio of 40:60 (v/v). The active ingredient of the drug content quantify with UV detector at 215 nm. The retention time of Remipril is 5.63 min. A good linearity relation (R2=0.999) was obtained between drug concentration and average peak areas. The limit of detection and limit of quantification of the instrument were calculated 0.03 and 0.09 µg/mL, respectively. The accuracy of the method validation was determined 102.72% by recoveries method.

The Dtermination of Paracetamol by HPLC Validation of the Method and Application on Serum Samples

2018 ◽  
Vol 69 (3) ◽  
pp. 627-631 ◽  
Author(s):  
Viorica Ohriac (Popa) ◽  
Diana Cimpoesu ◽  
Adrian Florin Spac ◽  
Paul Nedelea ◽  
Voichita Lazureanu ◽  
...  
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Hplc Analysis ◽  
Emotional Experience ◽  
Optimum Conditions ◽  
Serum Samples ◽  
Liquid Chromatograph ◽  
Mobile Phase Flow Rate ◽  
Quantification Limit

Pain is defined as a disagreeable sensory and emotional experience related to a tissue or potential lesion. Paracetamol (Acetaminophen) is the most used non-morphine analgesic. For the determination of paracetamol we developed and validated the high performance liquid chromatography (HPLC) analysis using a Dionex Ultimate 3000 liquid chromatograph equipped with a multidimensional detector. After determining the optimum conditions of analysis (80/20 water / acetonitrile mobile phase, flow rate 1.0 mL / min, detection wavelength 245 nm) we validated the method following the following parameters: linearity of response function, linearity of results, limit (LD = 0.66 mg / mL) and quantification limit (LQ = 2.00 mg / mL), and precision. The method of determining paracetamol by HPLC was applied to 30 samples of serum collected from patients who had pain and were treated with paracetamol.

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