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.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR RILPIVIRINE HYDROCHLORIDE IN BULK AND USE IN ANALYSIS OF PREPARED NANOSUSPENSION

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (04) ◽  
pp. 42-46
Author(s):  
Madhuri Manchala ◽  
◽  
Vijaya Sri Kanagala ◽  
Ganapath Vinay Jain
Keyword(s):  
Homogenization Method ◽  
Hplc Method ◽  
Array Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Photodiode Array Detector ◽  
Photodiode Array ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise, accurate and robust RP-HPLC-PDA method was developed and validated for the determination of rilpivirine hydrochloride in tablet dosage forms. Reverse-phase chromatography was performed on a BDS hypersil (250 mm × 4.6 mm, 6 μm) column of Waters HPLC with Empower software and with a photodiode array detector. Methanol: acetonitrile: water 80:13.5:6.5 (v/v) was used as the mobile phase at a flow rate of 1 mL min-1 with PDA detection at 306 nm. Rilpivirine hydrochloride nanosuspension was prepared by using an ultrasonic homogenization method. Linearity was observed in the concentration range of 0.1–10 μg mL-1 with regression equation y = 508856X+46908 (R2 = 0.9998). The method was validated as per ICH guidelines. The RSD for intra-day (1.31- 0.67) and inter-day (1.69-1.59) precision was found to be less than 2%. The developed method is simple, precise and robust for the determination of rilpivirine hydrochloride and is successfully applied for the nanosuspension.

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.

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.

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 Development and validation of HPLC/DAD method for simultaneously determination of six prohibited substances in model matrices

2020 ◽  
Vol 32 (4) ◽  
pp. 276-280
Author(s):  
Zdravka Zaharieva ◽  
Dimitar Tanev ◽  
Dancho Danalev
Keyword(s):  
High Performance ◽  
Ammonium Acetate ◽  
Gradient Flow ◽  
Hplc Method ◽  
Array Detector ◽  
Diode Array Detector ◽  
Active Ingredients ◽  
Over The Counter ◽  
Development And Validation

The authorities have identified an emerging trend where over-the-counter products, represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement, weight loss, or bodybuilding. The tests have revealed the presence of some undesired substances like sildenafil, tadalafil, vardenafil, and their analogues in tainted sexual enhancement products. The content of these substances is usually around the daily curative dose. A simple high-performance liquid chromatography (HPLC) method for simultaneously determination of sildenafil, vardenafil, tadalafil, dapoxetine, yohimbine, and sibutramine was developed and validated. InfinityLab Poroshell 120 EC-C18 (150 '4.6 mm '4 μm particles) was used, as well as a diode-array detector (DAD) at 230 nm, and a gradient flow with 0.030 М ammonium acetate buffer and acetonitrile. The method is linear in the following range: 2.5–37.5 μg/mL for yohimbine, 2.06–30.9 μg/mL for vardenafil, 2.0–30.0 μg/mL for sildenafil, 3.1–46.5 μg/mL for tadalafil, 1.98–29.7 μg/mL for dapoxetine, and 2.2–66.0 μg/mL for sibutramine. The linearity coefficient is R2 = 1 for all substances. Model matrices were spiked, and the analytical recoveries for all substances are in the range 97.5%–99.5%. The method exhibited an upper hand compared with previously reported methods in terms of speed and simplicity. Additionally, the mobile phase (also used as extracting, column washing, and diluting solvent) was composed of only buffer and acetonitrile, which rendered the method much cheaper than others.

scholarly journals Bioanalytical method development and validation of garenoxacin mesylate in human plasma by RP-HPLC

2019 ◽  
Vol 10 (2) ◽  
pp. 1314-1320
Author(s):  
Ajitha A ◽  
Sujatha K ◽  
Abbulu K
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Column Temperature ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

A simple, precise, accurate Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed for the estimation of Garenoxacin mesylate in human plasma using Ciprofloxacin Hydrochloride as an internal standard. Chromatographic conditions used are stationary phase Zorbax Eclipse XDB C18 (250x4.6 mm, 5m), Mobile phase 0.1% orthophosphoric acid and Acetonitrile in the ratio of 50:50 (% v/v) and flow rate was maintained at 1.0 ml/min, detection wavelength was 240 nm, injection volume of 50 µL and the column temperature was set to 30°C. The retention time of Garenoxacin mesylate was found to be 4.0 min. % Coefficient of Variation of the Garenoxacin mesylate was found to be 4.30. % Recovery was obtained as 98.97%. The linearity of the proposed method was established in the concentration range of 0.04 to 4 µg/ml (Correlation Coefficient = 0.999). The lower limit of quantification was 0.04 μg/ml (S/N Ratio 21) which reach the level drug possibly found in human plasma. Further, the reported method was validated as per the ICH guidelines and found to be well within the acceptable range.

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.

scholarly journals Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

2017 ◽  
Vol 2 (03) ◽  
pp. 41-45
Author(s):  
Sireesha D ◽  
Sai Lakshmi E ◽  
Sravya E ◽  
Vasudha Bakshi
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Room Temperature ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Isocratic Mode

A new simple, rapid, specific, accurate, precise and novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the estimation of Sitagliptin Phosphate in the pharmaceutical dosage form. The chromatographic separation for Sitagliptin was achieved with mobile phase containing methanol, Thermoscientific C18 column, (250x4.6 particle size of 5μ) at room temperature and UV detection at 248 nm. The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Sitagliptin was 1.91min. The above method was validated in terms of linearity, accuracy, precision, LOD and LOQ in accordance with ICH guidelines.

QBD BASED RP-HPLC METHOD FOR SCREENING AND ANALYSIS OF TELAPRAVIR AND 7 OTHER ANTIRETROVIRAL AGENTS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (02) ◽  
pp. 20-33
Author(s):  
N. S Kumar ◽  
◽  
R Kumaraswamy ◽  
S. Shantikumar ◽  
D. Paul
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Full Factorial

The present study describes the separation and simultaneous estimation of eight anti-retroviral drugs, namely, Telaprevir (TPV), Emtricitabine (ECB), Fosamprenavir (FANV), Tenofavir (TNF), Ritonavir (RNV), Raltegravir (RGV) and Oseltamivir (OSMV) and Zidovudine (ZDV) as an active pharmaceutical ingredient, by RP-HPLC method by applying the principles of Quality by Design (QbD). An application of DoE (Design of Experiments) full factorial design was used for initial screening and optimization. The final optimized method consists of separation being carried out on a Fortis C18 column (150 mm × 4.6 mm, 5μ particle size) using acetonitrile and 10 mm ammonium formate buffer (pH 3 adjusted with formic acid) using a gradient program. The quantitative evaluation was performed with a diode array detector at 251 nm and 230 nm with a flow rate of 1 mL min–1. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the International Conference on Harmonization (ICH) guidelines. The method is selective, precise, robust and accurate and can be used for routine analysis of pharmaceutical formulations in quality control and counterfeit screening.

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