scholarly journals Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Satranidazole from Its Formulation

2014 ◽  
Vol 2014 ◽  
pp. 1-7
Author(s):  
Harshal Ashok Pawar ◽  
Pooja Rasiklal Joshi
Keyword(s):  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Solution Ph ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Eudragit E100 ◽  
Development And Validation

Satranidazole is a new nitroimidazole derivative with potent antiamoebic action and is available in market in the form of tablet and dry syrup either alone or in combination with Ofloxacin. The present study involves the development of simple, accurate, precise, and reproducible reversed phase high performance liquid chromatography (RP-HPLC) method for determination of Satranidazole from its granular dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on BDS Hypersil C18 (250 mm × 4.6 mm, 5 μm) column at 25°C temperature. The mobile phase consists of 0.16% v/v orthophosphoric acid solution, pH 3: acetonitrile in the ratio of 60 : 40 v/v. The UV detection wavelength was 320 nm, and 20 μL sample was injected. The retention time for Satranidazole was about 4.3 minutes. The method was validated for various parameters such as system suitability, precision, recovery, robustness, and ruggedness as per ICH guidelines. The validated RP-HPLC method was found to be specific, linear, precise, and accurate and can be successfully employed for the assay of Satranidazole taste masked granules coated with Eudragit E100 and marketed tablets.

scholarly journals ANALYITCAL METHOD DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY FOR THE DETERMINATION OF MODAFINIL IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2016 ◽  
Vol 9 (5) ◽  
pp. 177
Author(s):  
Bijithra Cholaraja ◽  
Shanmugasundaram P ◽  
Ragan G ◽  
Sankar Ask ◽  
Sumithra M
Keyword(s):  
Particle Size ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Rp Hplc ◽  
Development And Validation

ABSTRACTObjective: To development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) for the determination of modafinilin bulk and pharmaceutical dosage forms.Methods: A simple, precise, rapid, and accurate RP-HPLC method was developed for the estimation of modafinil in bulk and pharmaceutical dosageforms. Xterra RP 18 (250 mm × 4.6 mm, 5 µ particle size) with a mobile phase consisting of methanol:water 70:30 V/V was used. The flow rate1.0 ml/min and the effluents were monitored at 260 nm. The retention time and recovery time was 12 minutes. The detector response was linear inthe concentration of 10-50 µg/ml. The respective linear regression equation being Y=452.1x+65237. The limit of detection and limit of quantificationwere 4.547 and 1.377 mcg, respectively. The method was validated by determining its accuracy, precision, and system suitability.Result: The objective of the present work is to develop simple, precise, and reliable HPLC method for the analysis of modafinil in bulk andpharmaceutical dosage forms. This is achieved using the most commonly employed Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size) columndetection at 260 nm. The present method was validated according to ICH guidelines.Conclusion: In this study, a simple, fast and reliable HPLC method was developed and validated for the determination of modafinil in pharmaceuticalformulations.Keywords: Modafinil, Reversed-phase high-performance liquid chromatography, Estimation, ICH guidelines, Tablets. 

DEVELOPMENT AND VALIDATION OF NEW RP–HPLC METHOD FOR DETERMINATION OF BESIFLOXACIN IN ANIMAL MODEL

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (01) ◽  
pp. 26-32
Author(s):  
A Singh ◽  
◽  
C. L Singh ◽  
S. Kumar ◽  
M. Kumar
Keyword(s):  
High Performance ◽  
Internal Standard ◽  
Rat Plasma ◽  
Reversed Phase ◽  
Hplc Method ◽  
Standard Curve ◽  
Absorbance Detection ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

A sensitive and accurate reversed– phase high performance liquid chromatography (RP-HPLC) method with UV absorbance detection at 289 nm was developed and validated for the determination and quantification of besifloxacin (BSF) in rat plasma. Ofloxacin was used as an internal standard (IS). The sample was prepared by liquid extraction of BSF from plasma, using methanol and acetonitrile (70:30). The chromatographic separation was achieved with octadecylsilane (ODS-3), Hypersil® C18 column (250 mm×6mm×5μm). The chromatographic runtime was less than 5 minutes where the retention time of internal standard and the drug was 2.15 min and 3.30 min respectively. A standard curve with a regression coefficient (r2) 0.999 was obtained in the range of 0.025-20 μg/mL. The method was validated with respect to linearity, range, precision, accuracy and robustness according to ICH guidelines. The method was found to be accurate and robust with a runtime of less than 5 minutes. Hence, the present method was rapid and economical to use for clinical studies as well as to analyze the drug in different plasma samples.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF EDOXABAN TOSYLATE IN TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (07) ◽  
pp. 47-51
Author(s):  
B. Anupama ◽  
P. Tejaswi ◽  
KNV. Chenchu Lakshmi ◽  
A. Vishwanadh
Keyword(s):  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Isocratic Mode

A rapid, simple and precise reversed phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of edoxabantosylate in tablets. The quantification was carried out using a Phenomenex C-18 column (250×4.6 mm i.d., 5µm particle size) in isocratic mode with mobile phase comprising of ammonium acetate buffer andacetonitrile in the ratio of 50:50 (V/V) at a flow rate 1 mL/min. The eluent was monitored at 240 nm. The retention time of the drug was 3.486 min. The calibration curve was linear in the concentration range of 5-25 µg/mL and per cent recovery ranged from 98.25-101.6.The developed method was validated as per ICH guidelines and the results obtained were satisfactory.The method can be applied for routine quality control analysis of edoxabantosylate in tablet dosage forms.

scholarly journals Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Sofosbuvir, Velpatasvir, and Voxilaprevir in Tablet Formulation

2020 ◽  
pp. 7-14
Author(s):  
Deepthi R ◽  
Gowri Sankar D
Keyword(s):  
High Performance ◽  
Hplc Method ◽  
Solution Stability ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Optimized Conditions

Objective: The present study aimed to develop a stability-indicating reverse-phase high performance-liquid chromatography (RP-HPLC) method for the estimation of Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form and validated in accordance with ICH guidelines. Methods: The optimized conditions for the developed RP-HPLC method are Agilent C18 (250 mm×4.6mm, 5μ) column maintained at 30ºC with a mobile phase consisting of Buffer(0.1%OPA) and Acetonitrile taken in the ratio 55:45%v/v on isocratic mode at flow rate 1.0ml/min. The sample was detected at 220 nm. Results: The retention time of Sofosbuvir, Velpatasvir, and Voxilaprevir was found to be 2.17, 2.731 and 3.55 min respectively. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness and solution stability.

Development and validation of an RP-HPLC method for the simultaneous determination of total withanolide glycosides and Withaferin A in Withania somnifera (Ashwagandha)

2020 ◽  
Vol 7 (2) ◽  
pp. 106-120
Author(s):  
Benny Antony ◽  
Merina Benny ◽  
Binu T. Kuruvilla ◽  
Anu Sebastian ◽  
Anu Aravind Aravindakshan Pillai ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Quantitative Determination ◽  
High Performance ◽  
Withania Somnifera ◽  
Reversed Phase ◽  
Hplc Method ◽  
Withaferin A ◽  
Rp Hplc ◽  
Ich Guidelines

Background:: Withanolide glycosides in Ashwagandha (Withania somnifera), are important metabolites attributed with widely acclaimed therapeutic potential for which validated methods for quantitative determination are limited. Objective:: The primary objective was to develop and validate a Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method for simultaneous quantification of total withanolide glycosides (WG), withanoside IV and withaferin A present in ashwagandha extract.The study also aimed to identify various other constituents present in the extract. Materials and Methods: Aqueous methanol extract (AME) of Ashwagandha was prepared and fractionated into two viz. flavonoid rich fraction (FF) and withanolide rich fraction (WF). RP-HPLC method was developed and validated for the estimation of total WG in ashwagandha extract according to ICH guidelines. Preparative HPLC based purification of major compounds from WF fraction was carried out and constituents were identified using spectroscopic techniques. HPLC chemical profiling of WF before and after acid hydrolysis under controlled conditions was carried out to further confirm the glycosidic compounds. Results and Discussion: The RP-HPLC method gave a precise differentiation of flavonoids, withanolides and WG present in ashwagandha extract. The method demonstrated good reliability and sensitivity, and can be conveniently used for the quantification of total WG, withanoside IV and withaferin A present in ashwagandha extracts. According to this method, a purified fraction (WF) prepared from roots and leaves of Ashwagandha comprise 35% of total WG, 3.27% of withanoside IV and 2.40% of Withaferin A. The method was also applied to different products prepared from Ashwagandha with total withanolide glycosides ranged from 1.5% to 60%, and the results were found to be reproducible. Identification of the individual chemical constituents as well as the acid hydrolytic pattern of the extract further supported the reliability of the developed method for the quantitative determination of total WG. This study also reported a new withanolide glycoside named, cilistol V-6’-O-glucoside (Aswanoside) along with some other known withanolide glycosides. Conclusion:: A Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of total WG, withanoside IV and withaferin A present in ashwagandha extract according to ICH guidelines. This study also reported a new withanolide glycoside named, cilistol V-6’-O-glucoside (Aswanoside) along with some other known WG.

Development and Validation of Stability Indicating RP-HPLC Method for Determination of Enzalutamide

2019 ◽  
Vol 12 (5) ◽  
pp. 4635-4645
Author(s):  
Pankaj Padmakar Nerkar ◽  
Sameer Ansari ◽  
Shailesh Chalikwar
Keyword(s):  
Ammonium Acetate ◽  
Correlation Coefficients ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

A simple, isocratic, and accurate reversed phase HPLC method was developed for the quantitative determination of enzalutamide. The chromatographic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5 μm) column using methanol: ammonium acetate buffer pH 4.2 adjusted with glacial acetic acid: (60:40, v/v) as a mobile phase, at a flow rate of 1 ml/min and detection at 236nm. The linear range for enzalutamide were 2.0 to        10 μg/mL was obtained with correlation coefficients ≥ 0.998. The retention time was found to be 6.30min. Enzalutamide was subjected to stress conditions hydrolysis (acid, base) oxidation, photolysis and thermal degradation and the stressed samples were analysed by the developed method. The method was validated for the precision, accuracy, linearity and robustness. The developed stability indicating method for enzalutamide was validated as per ICH guidelines.

Development and Validation of RP-HPLC Method for Determation of Acyclovir in Ointment

2021 ◽  
pp. 199-202
Author(s):  
Ajay Bedadurge ◽  
Kadare Mahesh ◽  
Vinod Matole ◽  
Parikshit Shirure ◽  
Sainath Suryawanshi ◽  
...  
Keyword(s):  
High Performance ◽  
Hplc Method ◽  
Array Detector ◽  
Diode Array Detector ◽  
Column Temperature ◽  
Development Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

The analytical method was developed and validated for determination of acyclovir in ointment by High performance liquid chromatography. The separation was carried out on Luna C18 column (250 × 4.6mm × 5µ). The mobile phase consists of water: acetonitrile in the ratio 88:12 at flow rate 0.8ml/min with diode array detector wavelength at 254nm.The column temperature was adjusted at 30ºC±40ºC with injection volume 20µl.The retention time of acyclovir was 4.747min. The linearity of the calibration curve was linear over the concentration range 80-120µg/ml (r2=0.9996). The validation was carried out as per ICH guidelines. The development method was easy, rapid, linear, precise, accurate and consistent.

scholarly journals Development and validation of a new analytical RP-HPLC method for simultaneous determination of Glibenclamide and Atenolol in bulk

2019 ◽  
Vol 10 (3) ◽  
pp. 2433-2445
Author(s):  
Anitha P ◽  
Ramkanth S ◽  
Satyanarayana S V
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Development And Validation ◽  
First Time

A new, simple, reliable, fast, sensitive and economical RP-HPLC method was developed and validated for simultaneous estimation of two fixed-dose combinations frequently prescribed in coexisted chronic diseases such as diabetes (GLB) and hypertension (ATN) in bulk for the first time. The mobile phase used for the chromatographic runs consisted of 0.01N potassium dihydrogen ortho phosphate (pH 4.8) and acetonitrile (55:45, v/v). The separation was achieved on column (BDS C18 250 x 2.1mm, 1.6m) using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 235.0 nm. The method was linear at the concentration range 2.5-15µg/ml for Glibenclamide (GLB) and 6.25-37.5µg/ml for Atenolol (ATN), respectively. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The method was validated for system suitability, linearity, accuracy, precision, detection, quantification limits and robustness and was found it is acceptable in the range of 2.5–15 µg/ml for GLB and 6.25–37.5 µg/ml for ATN. The LOD and LOQ of GLB was found to be 0.48 µg/ml and 1.47µg/ml and for ATN was found to be 0.72µg/ml and 2.20 µg/ml, respectively. The method was applied to drug interaction studies of GLB with ATN to illustrate the scope and application of the methods to manage two different therapeutic classes of drugs, as they may co-administered in concurrent diseases.

scholarly journals Development and Validation of RP-HPLC Method for the Determination of Ganciclovir in Bulk Drug and in Formulations

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
P. J. Ramesh ◽  
K. Basavaiah ◽  
K. B. Vinay ◽  
Cijo M. Xavier
Keyword(s):  
Ammonium Acetate ◽  
Reversed Phase ◽  
Hplc Method ◽  
Column Temperature ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Percent Recovery ◽  
Bulk Drug ◽  
Development And Validation

A simple, rapid, accurate, and precise gradient reversed-phase HPLC (RP-HPLC) method has been developed for the determination of ganciclovir (GNC) in pharmaceuticals. Chromatographic separation was carried out on inertsil ODS C18 (4.6 mm  mm, 5.0 μm) LC column using ammonium acetate buffer, sodium salt of hexane sulfonic acid as ion-pairing reagent in 1000 mL water, and acetonitrile (90 : 10) (v/v) as mobile phase at a flow rate of 1.0 mL  and with UV detection at 245 nm at column temperature (30°C). The runtime under these chromatographic conditions was 10 min. The method was linear over the range of 0.02–75 μg . The limits of detection (LOD) and quantification (LOQ) values were 4.1 and 20 ng , respectively. The method was successfully extended to study the effect on GNC upon treatment with 2 N NaOH, 2N HCl, and 5% H2O2 for 2 hrs at 80°C and upon exposure to UV (1200 K lux hrs) for 72 hrs and thermal (105°C) for 5 hrs. The proposed method was further applied to the determination of GNC in pharmaceuticals, with good percent recovery. The accuracy and the precision of the method were validated on intraday and interday basis in accordance with ICH guidelines.

Development and validation of a fast and simple HPLC method for the simultaneous determination of aniline and its degradation products in wastewater

2016 ◽  
Vol 8 (30) ◽  
pp. 5949-5956 ◽  
Author(s):  
Soumia Boulahlib ◽  
Ali Boudina ◽  
Kahina Si-Ahmed ◽  
Yassine Bessekhouad ◽  
Mohamed Trari
Keyword(s):  
High Performance ◽  
Degradation Products ◽  
Reversed Phase ◽  
Hplc Method ◽  
Array Detector ◽  
Simple Method ◽  
Photodiode Array Detector ◽  
Photodiode Array ◽  
Development And Validation

In this study, a rapid and simple method based on reversed-phase high performance liquid chromatography (RP-HPLC) using a photodiode array detector (PDA) for the simultaneous analysis of five pollutants including aniline and its degradation products, para-aminophenol, meta-aminophenol, ortho-aminophenol and phenol, was developed.

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