A green HPLC method for the analysis and stability study of flavoxate HCl using micellar eluent

2014 ◽  
Vol 6 (4) ◽  
pp. 1001-1010 ◽  
Author(s):  
Rania Nabih El-Shaheny ◽  
Nahed Mahmoud El-Enany ◽  
Fathalla Fathalla Belal
Keyword(s):  
Hplc Method ◽  
Stability Study ◽  
Degradation Behavior ◽  
Ich Guidelines ◽  
Flavoxate Hcl ◽  
Comprehensive Study

We report the first micellar HPLC method for the assay and comprehensive study of the degradation behavior of flavoxate HCl as per ICH guidelines.

scholarly journals A Fast and Validated HPLC Method for Simultaneous Determination of Dopamine, Dobutamine, Phentolamine, Furosemide, and Aminophylline in Infusion Samples and Injection Formulations

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Fuchao Chen ◽  
Baoxia Fang ◽  
Sicen Wang
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Stability Study ◽  
Precision Data ◽  
Column Temperature ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
The Stability

A simple, fast, and validated HPLC method was developed for the simultaneous quantization of five cardiovascular agents: dopamine (DPM), dobutamine (DBM), phentolamine (PTM), furosemide (FSM), and aminophylline (APL) either in infusion samples or in an injection dosage form. The proposed method was achieved with a 150 mm × 4.6 mm, 5.0 μm C18 column, by using a simple linear gradient. Mobile phase A was buffer (50 mM KH2PO4) and mobile Phase B was acetonitrile at a flow rate of 1.0 mL/min. The column temperature was kept at 30°C, and the injection volume was 20 μL. All analytes were separated simultaneously at a retention time (tr) of 3.93, 5.84, 7.06, 8.76, and 9.67 min for DPM, DBM, PTM, FSM, and APL, respectively, with a total run time of less than 15.0 min. The proposed method was validated according to ICH guidelines with respect to accuracy, precision, linearity, limit of detection, limit of quantitation, and robustness. Linearity was obtained over a concentration range of 12.0–240.0, 12.0–240.0, 20.0–200.0, 6.0–240.0, and 10.0–200.0 μg/mL DPM, DBM, PTM, FSM, and APL, respectively. Interday and intraday accuracy and precision data were recorded in the acceptable limits. The new method has successfully been applied for quantification of all five drugs in their injection dosage form, infusion samples, and for evaluation of the stability of investigated drugs in mixtures for endovenous use. The results of the stability study showed that mixtures of DPM, DBM, PTM, FSM, and APL in 5% glucose or 0.9% sodium chloride injection were stable for 48 hours when stored in polypropylene syringes at 25°C.

Fast HPLC Method for the Determination of Piroxicam and its Application to Stability Study

2017 ◽  
Vol 68 (4) ◽  
pp. 701-706 ◽  
Author(s):  
Alina Diana Panainte ◽  
Madalina Vieriu ◽  
Gladiola Tantaru ◽  
Mihai Apostu ◽  
Nela Bibire
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Calibration Graph ◽  
Stability Study ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
System Suitability ◽  
Optimum Separation

A fast and robust RP-HPLC isocratic method was developed for determination of piroxicam in bulk materials and pharmaceutical formulations. Optimum separation of piroxicam and stress induced degradation a product was achieved using a SB-C18 Eclipse column (150x4.6; 5�m). The mobile phase was a mixture of water: acetonitrile (50:50) with a flow rate of 0.5mL/min. The UV detection was performed at 360nm. The method was validated in accordance with the current ICH guidelines in terms of linearity, limit of detection, limit of quantification, precision, accuracy, recovery and system suitability. The retention time for piroxicam was 2.55 min. The calibration graph was linear in the concentration range 5-90�g/mL. The assay proved to be sensitive, specific and reproducible. The method was applied for the determination of piroxicam in tablets.

scholarly journals Stability indicating RP-HPLC method for the simultaneous estimation of Quercetin and Rutin in bulk drug

2020 ◽  
Vol 11 (1) ◽  
pp. 1254-1258
Author(s):  
Gomathy Subramanian ◽  
Narenderan S T ◽  
Meyyanathan S N
Keyword(s):  
Hplc Method ◽  
Stability Study ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Photolytic Degradation ◽  
Ich Guidelines ◽  
Stress Degradation ◽  
Bulk Drug ◽  
The Stability ◽  
Excellent Reproducibility

A stability-indicating HPLC technique has been developed and validated for Quercetin and Rutin under different stability environments of acid, base, neutral, oxidative, and photolytic degradation. The stability study were executed according to the ICH guidelines. The separation was accomplished utilizing Phenomenex Luna C18 (250 x 4.6mm i.d, 5µ) column at a detection wavelength of 259 nm utilizing the mobile phase established of 20mM Ammonium acetate (pH 3.0) and  acetonitrile 60: 40, v/v at the flow rate of 1.0 ml/min and injection volume of 20 µl. The linearity of the developed technique was obtained over the range of 1-5 µg/ml and 0.1-0.5 µg/ml for Quercetin and Rutin, respectively, with a correlation coefficient of more than 0.99. Further, the stress degradation studies were performed for which the results obtained stated that Quercetin and Rutin were more susceptible to acidic and oxidative conditions. The developed method provides good sensitivity and excellent reproducibility and can be further used to study the stability in formulations.

Forced Degradation Studies of Sofosbuvir with a Developed and Validated RP-HPLC Method as per ICH Guidelines

2021 ◽  
Author(s):  
Abderrazaq Hamdache ◽  
Lamia Grib ◽  
Celia Grib ◽  
Lydia Adour ◽  
Hakim Zatout ◽  
...  
Keyword(s):  
Hplc Method ◽  
Forced Degradation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Forced Degradation Studies ◽  
Degradation Studies

RP-HPLC METHOD FOR ESTIMATION OF LORNOXICAM IN TABLETS AND IN DISSOLUTION SAMPLES USING MASS SPECTROMETRIC COMPATIBLE BUFFERS

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (07) ◽  
pp. 32-37
Author(s):  
Vijaya Lakshmi Marella ◽  
Chaitanya S. N ◽  
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Mass Spectrometric ◽  
Control Analysis ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Liquid Chromatographic

A selective and sensitive reverse phase High Performance Liquid Chromatographic method has been developed and validated for the estimation of lornoxicam in bulk, pharmaceutical dosage forms and in dissolution samples. The analysis was performed isocratically on an Inertsil column (250* 4.6 mm, 5 µm) using a mass spectrometric compatible mobile phase of 10 mM ammonium acetate: acetonitrile (50:50 V/V) at a flow rate of 1 mL/min.The detection wavelength was 290 nm. The retention time was found to be 4.573 min for lornoxicam. The linearity of the method has been satisfied with Beer Lambert’s law in the concentration range of 5-25 µg/mL with a correlation coefficient of 0.9988. The mean recoveries assessed for lornoxicam were in the range of 100.39-101.86 %, indicating good accuracy of the method. The limit of detection and limit of quantification were found to be 0.03 and 0.11 µg/mL, respectively. The developed method has been statistically validated in accordance with ICH guidelines and found to be mass spectrometric compatible, simple, precise, and accurate with the prescribed values. Thus, the proposed method was successfully applied for the estimation of lornoxicam in routine quality control analysis of bulk, formulations and in dissolution samples.

HPLC METHOD DEVELOPMENT FOR ESTIMATION OF RAMELTEON IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 20-23
Author(s):  
S Sahoo ◽  
◽  
P. K. Panda ◽  
S. K. Mishra
Keyword(s):  
Flow Rate ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Tablet Dosage ◽  
Good Agreement

A simple, fast, accurate and precise reverse phase HPLC method is developed and described for the determination of ramelteon in tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and phosphate buffer pH 7.0 (35:65 V/V) as the mobile phase at a flow rate of 1.0 mL/min with detection at 286 nm. The retention time of the drug was 7.7 min. The procedure was validated for linearity, precision, accuracy, and robustness. The developed method was validated for linearity from 50 to 150% which shows the method is quite linear with a correlation coefficient of 0.999, for precision which includes system precision, method precision, intraday and by another analyst on another day, and accuracy. The %RSD for system precision was observed to be 1.1, whereas the method precision was observed to be 0.2. The % recovery from ‘accuracy’ studies yielded the recovery of 99.7-101.5% which indicates the capability of the method, and finally for robustness that includes studies w.r.t. change in flow rate, the percentage of organic modifier and pH. As per ICH guidelines, method validation results are in good agreement. The proposed method was simple, sensitive, precise and accurate.

RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY OF AMPHOTERICIN B

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (02) ◽  
pp. 16-20
Author(s):  
L Mohankrishna ◽  
◽  
P. J. Reddy ◽  
B. P Reddy. ◽  
P. Navya
Keyword(s):  
Amphotericin B ◽  
Mobile Phase ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Phase Combination ◽  
Hplc Method Development

A sensitive and precise HPLC procedure has been developed for the assay of amphotericin B in bulk samples and pharmaceutical formulations by using a C18 column [Kromosil, C18, (5 µm, 4.6mm x 250 mm; Make. Waters)], and mobile phase combination is 1% formic acid in water and acetonitrile in ratio of 45:55 V/V. The procedure has been validated as per the ICH guidelines. The λmax of detection was fixed at 407 nm, so that there was less interference from mobile phase with highest sensitivity according to UV analysis. Calibration plots were linear in the range of 10-100 µg/mL and the LOD and LOQ were 0.02 µg/mL and 0.06 µg/mL respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of amphotericin B in different formulations.

DEVELOPMENT, VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TENOFOVIR DISPROXIL FUMARATE, EMTRICITABINE AND RILPIVIRINE HYDROCHLORIDE IN BULK, FORMULATION AND USED IN NANOSUSPENSION

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (09) ◽  
pp. 43-54
Author(s):  
K Vijaya Sri ◽  
M. Madhuri ◽  
V. Anusha ◽  
V.R.K. Siresha ◽  
Keyword(s):  
Research Work ◽  
Multicomponent System ◽  
Hplc Method ◽  
Combination Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Line Of Therapy ◽  
Development And Validation

The present research work illustrates the development and validation of RP HPLC method for simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride in bulk and formulated in a pharmaceutical dosage form as a nanosupension. Antiretroviral drug treatment is the primary line of therapy for treating HIV. The multicomponent system formulated as a nanosuspension evidenced increased hydrophilicity, potency and decreased side effects. The separation was carried out by using efficient BDS hypersil C18 HPLC column with empower software. Combination method of Precipitation—ultrasonic homogenization was used for the preparation of the nanosuspension. The mobile phase used was methanol, water, acetonitrile (80:13.4:6.6) v/v and flow rate 1mL /min. The developed method was thus validated as per ICH guidelines for various parameters whose results advocated the reliability of the method. The results for parameters viz. retention times of tenofovir disproxil fumarate, emtricitabine and rilpivirine were 3.09 min, 2.78 min and 3.68 min, linearity range was between 7.5-90, 5-60, 0.625-7.5µg/mL, respectively. Thus the new RP-HPLC method is optimum, reliable and can be used for the simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride.

scholarly journals Simultaneous determination of clobutinol hydrochloride and doxylamine succinate from syrups by RP HPLC using a new stationary phase containing embedded urea polar groups

2012 ◽  
Vol 48 (2) ◽  
pp. 315-323 ◽  
Author(s):  
Paulo Cesar Pires Rosa ◽  
Isabel Cristina Sales Fontes Jardim
Keyword(s):  
Stationary Phase ◽  
Simultaneous Determination ◽  
Reversed Phase ◽  
Hplc Method ◽  
Array Detector ◽  
Polar Groups ◽  
Ich Guidelines ◽  
Relative Standard ◽  
New Stationary Phase

A new, simple, fast, reproducible and sensitive reversed phase HPLC method, using a new stationary phase containing embedded urea polar groups, has been developed and validated for the simultaneous determination of clobutinol hydrochloride (CLO) and doxylamine succinate (DOX) in syrups. The determination was carried out on a C8 urea column (125 mm x 3.9 mm i.d., 5 µm particle size) synthetized at the Liquid Chomatography Laboratory (LabCrom) of the Chemistry Institute of Unicamp. The mobile phase consisted of a mixture of acetonitrile:methanol:phosphate buffer (pH 2.5) in the gradient mode. The diode array detector (DAD) was operated at 230 nm for CLO and 262 nm for DOX. The method showed adequate precision, with relative standard deviations (RSD) less than 1%. The presence of the excipients did not interfere in the results of the analysis. Accuracy was determined by adding standards of the drugs to a placebo and good recovery values were obtained. The analytical curves were linear (r² 0.9999 for CLO and 0.9998 for DOX) over a wide concentration range (2.4-336 µg mL-1 for CLO and 2.3-63 µg mL-1 for DOX). The solutions were stable for at least 72 hours at room temperature. The criteria for validation using the ICH guidelines were fulfilled.

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