DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR QUANTITATIVE ESTIMATION OF NUCIFERINE FROM LOTUS LEAVES

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (12) ◽  
pp. 37-41
Author(s):  
N. A. Patel ◽  
◽  
A. P. Jadhav
Keyword(s):  
Mobile Phase ◽  
Orthophosphoric Acid ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Quality And Safety ◽  
Herbal Drugs ◽  
Perennial Plant ◽  
Rp Hplc ◽  
Lotus Leaves ◽  
Development And Validation

Nelumbo nucifera Gaertn (Family: Nelumbonaceae), commonly known as lotus, is an aquatic perennial plant. The lotus leaves are used to treat fever, hematemesis, hyperlipidaemia and obesity. The leaves are rich in alkaloids such as nuciferine, roemerine, pronuciferine and N-nornuciferine. The present study describes simple, accurate, precise, robust RP-HPLC method to detect and quantitate nuciferine as a marker from lotus leaves. The marker was resolved using Hemochrom Intsil C-18 column, with mobile phase methanol:10mm phosphate buffer (85:15), pH adjusted to 4 (using orthophosphoric acid) at a flow rate of 1 mL/min. Retention time of nuciferine was 5.60±0.2 minutes at 272 nm. Linear responses were obtained in concentration range of 1 - 9 ppm for nuciferine with correlation coefficient (r2) of 0.9996. The developed method was applied for quantitation of marker from lotus leaves. This method can be used to evaluate nuciferine containing extracts, thus conforming to the need of ensuring quality and safety of herbal drugs.

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF BERBERINE AND CURCUMIN IN AN AYURVEDIC FORMULATION

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (08) ◽  
pp. 48-52
Author(s):  
K. P Parekh ◽  
◽  
A. P. Jadhav
Keyword(s):  
Mobile Phase ◽  
Herbal Medicines ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Quality And Safety ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Water Ph ◽  
Development And Validation

A simple, accurate, precise, robust stability indicating RP-HPLC method was developed and validated for simultaneous estimation of berberine and curcumin in an ayurvedic formulation. The two markers were resolved using a C-18 column using as the mobile phase methanol: water (pH 3 adjusted using acetic acid) in the ratio 75:25 V/V at a flow rate of 1mL/min. Retention times of berberine and curcumin were 2.58 ± 0.2 min and 8.5 ± 0.2 min, respectively at 358 nm. Linear response was observed in the concentration range of 2 – 8 ppm for berberine and 5 – 40 ppm for curcumin, with correlation coefficient (r2) of 0.994 and 0.998 for berberine and curcumin, respectively. The developed method was applied for quantitation of markers in marketed and in-house formulations of Gruhadhoomadi Churna. This method can also be used to evaluate formulations containing berberine and curcumin as markers, thus conforming to the need of ensuring quality and safety of herbal medicines.

DEVELOPMENT AND VALIDATION OF DETERMINATION FOR CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE AND IBUPROFEN IN BULK AND PHARMACEUTICAL FORMULATION BY RP-HPLC METHOD

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (11) ◽  
pp. 35-40
Author(s):  
V. B. Baviskar ◽  
◽  
S. T. Donda ◽  
S. S. Patil ◽  
P. K Deshmukh ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Orthophosphoric Acid ◽  
Pharmaceutical Preparation ◽  
Hplc Method ◽  
Chlorpheniramine Maleate ◽  
Phenylephrine Hydrochloride ◽  
Rp Hplc ◽  
Water Ph ◽  
Development And Validation

A simple, precise and accurate isocratic RP-HPLC method was successfully developed for the simultaneous determination of chlorpheniramine maleate (CPM), phenylephrine hydrochloride (PHE) and ibuprofen (IBU) in bulk and pharmaceutical preparation. The separation of the drugs was achieved using Inertsil ODS C18 column with mobile phase consisting of methanol and 0.1% triethylamine (55:45 V/V) in water, pH 3 (adjusted with orthophosphoric acid). These drugs were resolved successfully with retention time of 3.0 min for CPM, 4.6 min for PHE and 18.9 min for IBU, when the eluate was monitored at 240 nm. Linearity was found in the concentration range of 10 to 50 μg mL-1 for CPM, 25 to 125 μg mL-1 for PHE and 100 to 500 μg mL-1 for IBU, with a correlation coefficient (r2) of 0.9987, 0.9965 and 0.9998 for CPM, PHE and IBU, respectively. Thus, the proposed method can be successfully applied to the pharmaceutical preparation containing the above mentioned drugs without any interference of excipients.

A comparative technique using as Joint studying to prove structure and determination the Quantitative estimation of organic compound (Irbesartan) as drug in multicomponent tablet form

2019 ◽  
Vol 9 (o3) ◽  
Author(s):  
Imad Tarek Hanoon ◽  
Abed Mohammed Daheir AL-Joubory 2 ◽  
Marwa Mohamed Saied 3
Keyword(s):  
Mobile Phase ◽  
Chemical Structure ◽  
Quantitative Estimation ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Tablet Form ◽  
Rp Hplc ◽  
Percent Recovery

A simple , specific, accurate and precise RP-HPLC method was developed for determination of Irbesartan (IRB) in pharmaceutical dosage forms in tablets products and sachet using symmetry (L 1 ) column at 30°C . The signal was detected at 225 nm. A mobile phase dissolve 0.5 g of buffer potassium phosphate in 100 ml distilled water and adjust pH 2.7 , methanol and acetonitrile at ratio (40 :30 :30 ) . and flow rate 1.2ml/min -1 at pH=7.2 a mobile phase The percent recovery was detected 101 % and the linearity of concentration was 10-50 µg.ml -1 and supported this method by using (FT.I.R.) spectrum method for organic spectrophotometer to prove the chemical structure of this drug and some physical properties . we are obtained the result is identical of other literature . The proposed method was applied successfully for determination of the IRB in tablets products.

scholarly journals Development and Validation of Estimation of Genotoxic Impurity (Hydroxylamine Hydrochloride content) in Leflunomide by using RP-HPLC technique

2021 ◽  
Vol 37 (02) ◽  
pp. 493-498
Author(s):  
Mohan Bhatale ◽  
Neelakandan Kaliyaperumal ◽  
Gopalakrishnan Mannathusamy ◽  
Gurunathan Ramalingam
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Hydroxylamine Hydrochloride ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Intermediate Precision ◽  
Rp Hplc ◽  
System Suitability ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, selective, linear having accuracy and specific of reverse phase high-performance liquid chromatographic (RP-HPLC) method for determination of Genotoxic impurity Hydroxylamine Hydrochloride of drug Leflunomide is reported.The separation and analysis were done on YMC Triart C18 (4.6 mm x 150 mm), having particle size 3.0 μm. KH2PO4 in 2000 mL of purified water and 2 mL triethylamine with pH 2.5 with phosphoric acid is mobile phase-A while acetonitrile is mobile Phase-B with gradient program. The elution achieved with 1.50 mL/min flow rate and using UV detection at 230 nm wavelength. Selected column oven temperature is 45°C and auto sampler 5°C respectively. In this method linearity and accuracy of Hydroxylamine HCl covered with specification limit of LOQ to 150 % (i.e.3 to 23 ppm). The observed correlation coefficient is 0.99965 and recovery in between 99.07 to 114.94. In method precision (ie.repeatability) and intermediate precision (IP) observed % RSD of six spiked test preparation is below 5.0 %. The standard and sample were stable for 3 days when stored at 2 to 8°C temperature. In robustness studies system suitability parameters ie tailing factor, theoretical plates and %RSD does not show significant changes. The present RP-HPLC method is selective, robust, linear, and precise for detection of Hydroxylamine HCl.

scholarly journals Development and Validation of RP-HPLC for Estimation of Neratinib in Bulk and Tablet Dosage Form

2019 ◽  
Vol 11 (02) ◽  
Author(s):  
M Lakshmi Kanth ◽  
B Raj Kama
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Chromatographic Separation ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Rp Hplc ◽  
Monopotassium Phosphate ◽  
Development And Validation ◽  
Tablet Dosage

An accurate RP-HPLC method developed for the estimation of Neratinib in bulk and tablet dosage form. The method is and validated for parameters linearity, accuracy, suitability, specificity, precession, LOD, LOQ and robustness. An Altima column (150 mm × 4.6 mm × 5μ) used for chromatographic separation within a runtime of 6 min. The mobile phase buffer (monopotassium phosphate) and acetonitrile (60:40 v/v) with 0.1% formic acid is used. The flow rate maintained at 1.0 ml/min with the effluents monitored at 215 nm. The Neratinib analyzed at retention time of 4.001. The concentration linear over 30-180μg/ml with regression equation y = 6065.6x + 795.43 and regression co-efficient 0.999.

scholarly journals Method Development and Validation of RP-HPLC Method for the Estimation of Ormeloxifene

2017 ◽  
Vol 2 (03) ◽  
pp. 78-82
Author(s):  
Anusha Shivaraj ◽  
Shireesha Battula
Keyword(s):  
Mobile Phase ◽  
Room Temperature ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Isocratic Mode ◽  
Ich Guideline

A new simple, specific, accurate, precise RP-HPLC method has been developed for the estimation of Ormeloxifene. The chromatographic separation for Ormeloxifene was achieved with mobile phase containing methanol :ACN(70:30 v/v), agilent C18 column (4.6 x150 mm) 5 μ at room temperature and UV detection at 274nm.The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Ormeloxifene was found to be 2.497min. The method was validated according to ICH guideline for linearity, specificity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines.

Development of RP-HPLC Method for the Quantitative Estimation of Ofloxacin and Ornidazole in Combined Liquid Oral Dosage Forms

2013 ◽  
Vol 6 (1) ◽  
pp. 1972-1976
Author(s):  
Cylma Menezes ◽  
Varun G ◽  
Shyamkumar B ◽  
Reema N
Keyword(s):  
Mobile Phase ◽  
Dynamic Range ◽  
Quantitative Estimation ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Oral Dosage ◽  
Rp Hplc ◽  
Validation Parameters ◽  
Oral Dosage Forms

A simple, efficient and reproducible reversed phase high performance liquid chromatographic (RP-HPLC) method for the quantitative estimation of ofloxacin and ornidazole in bulk and in combined liquid oral dosage form has been developed and validated. The separation was carried out using thermohypersil phenyl column (250 mm × 4.6 mm, 5 μm) as stationary phase with isocratic flow and phosphate buffer (adjusted to pH 2.4 with ortho phosphoric acid): acetonitrile (87:13 v/v) as mobile phase. Mobile phase was maintained at a flow rate of 1.0 ml/min and UV detection was carried out at 294 nm. The retention time of ofloxacin and ornidazole was 10.40 and 5.69 min, respectively. All calibration curves showed good linear correlation coefficients within the tested limits (r2 > 0.9995). The linear dynamic range was 10-100 µg/ml and 25-250 µg/ml for ofloxacin and ornidazole respectively. Percentage recoveries for ofloxacin and Ornidazole were 100.48 % and 99.84 % respectively. All the analytical validation parameters were determined and found in the limit as per the International Conference on Harmonization (ICH) guidelines, which indicates the validity of the method. The validated method is also found to be accurate, precise and robust for the quantitative estimation of ofloxacin and ornidazole in combined liquid oral dosage forms.

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug

2010 ◽  
Vol 3 (2) ◽  
pp. 978-986
Author(s):  
Wamorkar V V ◽  
C S Ramaa ◽  
Manjunath S Y ◽  
V Malla Reddy
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Good Resolution ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation ◽  
Different Levels

RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the stress conditions such as acid, base, oxidation, heat and light as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, mobile phase composition and allied columns. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF LERCANIDIPINE IN BIOLOGICAL MATRICES

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (07) ◽  
pp. 49-53
Author(s):  
A Singla ◽  
◽  
Y. Paul ◽  
B. Singh
Keyword(s):  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Reversed Phase ◽  
Hplc Method ◽  
Biological Matrices ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Uv Visible ◽  
Development And Validation ◽  
Isocratic Mode

A simple, precise, accurate, reproducible and robust analytical method was developed using reversed phase HPLC for quantitative estimation of lercanidipine in biological matrices. The method was validated as per the ICH and FDA guidelines. Analysis of the drug was performed in an isocratic mode employing methanol and acetonitrile (74:26) as the mobile phase on a C18 column. UV-Visible detector at 219 nm was found to be suitable for drug estimation. Linearity was observed in the range of 5 and 500 ng/mL (p<0.001). Recovery was found to range between 96.26% and 100.67%. The % RSD values for method precision and system precision were found to be 0.437 and 1.58, respectively. Limit of detection (LOD) and limit of quantification (LOQ) were observed to be 0.20 ng/mL and 0.68 ng/mL, respectively.

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