scholarly journals RP-HPLC QUANTIFIABLE TECHNIQUE DEVELOPMENT FOR EVALUATING PREGABALIN AND ETORICOXIB COMBINATION IN TABLET AND BULK KINDS

2021 ◽  
pp. 152-156
Author(s):  
M. S. SWARNA PUSHPA ◽  
T. RAJA RAJESWARI
Keyword(s):  
Mobile Phase ◽  
Stress Testing ◽  
Sodium Perchlorate ◽  
Evaluation Study ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Technique Development

Objective: This evaluation study aims to initiate a relatively sensitive RP-HPLC quantifiable technique for evaluating pregabalin (PRBN) and etoricoxib (ETRB) combination in tablet and bulk kinds. Methods: PRBN and ETRB chromatographic evaluations were carried off using the “KNAUER C18 Eurospher II column (250 mm × 4.6 mm × 5 μ)”. The mobile phase (MBP) was driven into the KNAUER C18 Eurospher II column at a 1.0 ml/min run rate with an isocratic elution programme of 65% volume of 0.5 mmol sodium perchlorate 35% volume methanol, detected and evaluated the PRBN and ETRB content at 217 nm. Results: The analysis of PRBN and ETRB is executed inside a run period of 15 min. The RP-HPLC quantifiable technique was developed to separate PRBN and ETRB and likely degradants formed from stress testing by isocratic elution. The RP-HPLC quantifiable technique developed was successfully validated to existing ICH limit guidelines and was confirmed as robust, specific, accurate, selective, precise, sensitive, and linear. Conclusion: The RP-HPLC quantifiable technique developed here is more valuable and worthy for routine PRBN and ETRB analysis of tablets and bulk kinds.

RP-HPLC AND HPTLC STABILITY INDICATING ASSAY METHODS FOR IVERMECTIN IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (03) ◽  
pp. 32-42
Author(s):  
G. P Wani ◽  
◽  
S. B Jadhav
Keyword(s):  
Mobile Phase ◽  
Stress Testing ◽  
Hplc Method ◽  
Rp Hplc ◽  
Assay Methods ◽  
Photo Stability ◽  
Tablet Dosage ◽  
Hptlc Method ◽  
Alkaline Oxidation

Simple, rapid, precise, accurate RP-HPLC and HPTLC methods have been developed and validated for ivermectin in bulk and its marketed formulation. RP-HPLC method for drug was achieved on Grace C18 (250 mm X 4.6 ID, Particle size; 5 μ) column using mobile phase acetonitrile: 10 mM phosphate buffer (95:05 v/v) pH adjusted to 3 with o-phosphoric acid. Detection of drug was done at 245 nm. The retention time was found to be 5.83 min. HPTLC method for ivermectin was accomplished on a precoated silica gel aluminium plate 60F-254 (CAMAG Linomat 5), using toluene: methanol: glacial acetic acid (8:2:0.1 v/v/v) as a mobile phase. The densitometric scanning was performed at 245 nm which showed Rf 0.46 for ivermectin. The stress testing of the drug individually was carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions. The proposed methods were successfully applied for the determination of drug in bulk and its marketed formulation.

DEVELOPMENT AND VALIDATION OF RP-HPL C METHOD FOR THE ESTIMATION OF ASCORBIC ACID IN HEALTH DRINKS

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 43-47
Author(s):  
N. Mallikarjuna Rao ◽  
◽  
D. Gowri Sankar
Keyword(s):  
Particle Size ◽  
Ascorbic Acid ◽  
Acetic Acid ◽  
Mobile Phase ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Development And Validation

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of ascorbic acid in health drinks. Isocratic elution at a flow rate of 0.9mL/min was employed on a symmetry C18 column (250x4.6mm, 0.5μ in particle size) at ambient temperature. The mobile phase consisted of water with acetic acid: methanol 95:5% (V/V). The UV detection wavelength was 245 nm and 20μL sample was injected. The retention time for ascorbic acid was 4.61± 0.22 min. The percentage RSD for precision and accuracy of the method was found to be less than the method which was validated as per the ICH guidelines. The method was successfully applied for routine analysis of ascorbic acid in health drinks.

scholarly journals SIMULTANEOUS DETERMINATION OF TIGECYCLINE AND ITS POTENTIAL IMPURITIES BY A STABILITY-INDICATING RP-HPLC-UV DETECTION TECHNIQUE

2022 ◽  
pp. 75-82
Author(s):  
V. N. V. KISHORE ◽  
G. V. RAMANA
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Buffer Mixture ◽  
Bulk Drug ◽  
Tablet Dosage

Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms. Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10 mmol Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column. Results: At 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 2 and) were estimated with ranging from 75–450 µg/ml for Tigecycline and 1–6 µg/ml for both impurity 1 and 2. The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 0.126 µg/ml). Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.

scholarly journals Validated RP-HPLC Method for the Determination of Buspirone in Pharmaceutical Formulations

2011 ◽  
Vol 2011 ◽  
pp. 1-3 ◽  
Author(s):  
M. V. Basaveswara Rao ◽  
A. V. D. Nagendrakumar ◽  
Sushanta Maiti ◽  
Guttikonda Raja
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Tablet Dosage

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the rapid assay of the Buspirone in tablet dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on a symmetry C18 (250×4.6 mm, 5 μm in particle size) at ambient temperature. The mobile phase consisted of water : acetonitrile : methanol 45 : 35 : 20(V/V). The UV detection wavelength was 210 nm, and 20 μL sample was injected. The retention time for the Buspirone was 7.057 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method can be successfully applied for the routine analysis of Buspirone in tablet dosage form.

scholarly journals Stability Indicating RP-HPLC Assessment and Stability Testing of Tazarotene and Halobetasol in Lotion Formulation

2020 ◽  
Vol 32 (6) ◽  
pp. 1456-1462
Author(s):  
V.L.N. Balaji Gupta Tiruveedhi ◽  
Venkateswara Rao Battula ◽  
Kishore Babu Bonige
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Isocratic Elution ◽  
Limit Values ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A novel liquid chromatographic method was established and validated for the quantification of tazarotene and halobetasol in the presence of degradation products obtained during stress conditions. The liquid chromatographic method was based on isocratic elution on Knauer Eurospher II C18 (5 μm particle size, 250 mm × 4.5 mm) column using a mobile phase consisting of methanol, acetonitrile and 0.5 mM perchloric acid (40:45:15 v/v/v) mixture at flow rate of 0.9 mL/min. Quantization of tazarotene and halobetasol was done with UV detection at 234 nm. The method validity was assessed in agreement with the recommendations of the International Conference on Harmonization. Linearity, accuracy and precision were satisfactory over the concentration ranges of 2.25-13.5 and 0.5-3.0 μg/mL for tazarotene and halobetasol, respectively. Detection limit values of 0.006 μg/mL and 0.01 μg/mL were found for halobetsol and tazarotene, respectively, while the quantization limit values of 0.02 μg/mL and 0.033 μg/mL were found for halobetsol and tazarotene, respectively. The developed method is appropriate for routine analysis and quality control of tazarotene and halobetasol combination in lotion dosage form.

scholarly journals Stability Indicating RP-HPLC Method for the Analysis of Dacomitinib and its Related Impurities in Bulk and Oral Solid Dosage Formulations

2021 ◽  
pp. 187-199
Author(s):  
Venu Kamani ◽  
M. Sujatha ◽  
G. S. N. Koteswara Rao ◽  
N. Vinod Kumar
Keyword(s):  
Mobile Phase ◽  
Degradation Products ◽  
Small Cell Lung Carcinoma ◽  
Sodium Perchlorate ◽  
Growth Factor Receptor ◽  
Hplc Method ◽  
Cell Lung Carcinoma ◽  
Stability Indicating ◽  
Related Impurities ◽  
Rp Hplc

Dacomitinib is an epidermal growth factor receptor inhibitor prescribed for the treatment of metastatic non small-cell lung carcinoma. There are no reported significant official of HPLC methods that resolve the impurities and degradation products generated during stability studies. Therefore, an isocratic RP-HPLC-UV method was developed for the determination of Dacomitinib in the presence of its related impurities and degradation products. The separation of Dacomitinib, impurity 1 and 2 was achieved on Agilent ZORBAX Eclipse (250×4.6 mm; 5 µ id) column as stationary phase, 0.1M sodium perchlorate at pH 5.6, acetonitrile as mobile phase in the ratio of 20:80 (V/V) at a flow rate of 1.0 mL/min in isocratic condition as mobile phase and UV detection was carried at 253 nm. In the optimised conditions, well resolved and retained peaks were observed at a retention time of 5.8 min, 4.0 min and 7.7 min for Dacomitinib, impurity 1 and 2 respectively. In the developed method, a very sensitive detection limit of 0.06 and 0.025 µg/mL was observed for impunity 1 and 2 respectively. The calibration was observed to be within the concentration range of 20 – 200 µg/mL for Dacomitinib and 0.2 – 2 µg/mL for impurity 1 and 2. The proposed method was used to investigate the effective separation of impurities along with degradation compounds formed under different degradative conditions and confirms that the method is stability indicating. Hence it can be concluded that the method was found to be simple, sensitive, specific, accurate, linear, precise, rugged, robust, and useful for estimation and characterizing the stability of Dacomitinib, impurity 1 and 2.

scholarly journals A Validated RP-HPLC Method for the Estimation of Pizotifen in Pharmaceutical Dosage Form

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
M. V. Basaveswara Rao ◽  
A. V. D Nagendrakumar ◽  
Sushanta Maiti ◽  
N. Chandrasekhar
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Pharmaceutical Dosage Form ◽  
Reliable Determination ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for rapid assay of Pizotifen in pharmaceutical dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on Chromosil C18 (250 mm × 4.6 mm, 5 μm) column at ambient temperature. The mobile phase consists of methanol : acetonitrile in the ratio of 10 : 90 v/v. The UV detection wavelength was 230 nm, and 20 μL sample was injected. The retention time for Pizotifen was 2.019 min. The percent RSD for accuracy of the method was found to be 0.2603%. The method was validated as per the ICH guidelines. The method can be successfully applied for routine analysis of Pizotifen in the rapid and reliable determination of Pizotifen in pharmaceutical dosage form.

scholarly journals Application of Factorial and Doehlert Designs for the Optimization of the Simultaneous Separation and Determination of Antimigraine Drugs in Pharmaceutical Formulations by RP-HPLC-UV

2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Sami Jebali ◽  
Chaouki Belgacem ◽  
Mohamed Radhouen Louhaichi ◽  
Senda Bahri ◽  
Latifa Latrous El Atarche
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Sodium Perchlorate ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Pharmaceutical Products ◽  
Rp Hplc ◽  
Simultaneous Separation

A sensitive, precise, accurate, and specific isocratic reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous separation and determination of zolmitriptan, naratriptan, dihydroergotamine, ketotifen, and pizotifen in pharmaceutical formulations has been developed and validated. An experimental design was applied for the optimization of the chromatographic parameters. A two-level full factorial 2k was used for studying the interaction between the variables to be optimized: the percentage of acetonitrile in the mobile phase, mobile-phase pH, nature of the buffer, and column oven temperature. The most significant parameters are the percentage of acetonitrile and the mobile-phase pH. These significant parameters were optimized using the Doehlert matrix. The optimum separation was achieved by means of a Waters XBridge C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of acetonitrile and a 10 mM sodium perchlorate buffer (38 : 62, v/v) at a flow rate of 1.0 mL·min−1 and UV detection at 220 nm. The selectivity, method linearity, accuracy, and precision were examined as part of the method validation. The described method shows excellent linearity over a range of 30 to 70 μg·mL−1 for all compounds with correlation coefficients higher than 0.995. The standard deviations of the intraday and interday precision were between 0.75 and 1.94%. The validated method was successfully applied to perform routine analysis of these compounds in different pharmaceutical products such as syrups and tablets. In the presence of some preservatives, it was found that there were no peaks at the related peak locations.

scholarly journals DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GALLIC ACID, CURCUMIN AND PIPERINE IN AN AYURVEDIC FORMULATION

2020 ◽  
pp. 81-86
Author(s):  
MEHJABEEN SHAIKH ◽  
ARUNA P. JADHAV
Keyword(s):  
Gallic Acid ◽  
Mobile Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Robust Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Relative Standard ◽  
Water Ph ◽  
Development And Validation

Objective: The objective of the present work was to establish a simple, precise, accurate and robust method for simultaneous estimation of gallic acid, curcumin and piperine from the marketed ayurvedic formulation by liquid chromatography. Methods: The separation was carried out on Hemochrom C18 Column (250 mm × 4.6 mm ID, 5 µm pore size) with a mobile phase methanol: acetonitrile: water (pH 3.2adjusted by using orthophosphate acid) in the ratio 70:20:10v/v by isocratic elution modeat 25 °C and the flow rate was setat0.8 ml/min. The analysis was carried out atisoabsorptive wavelength of 295 nm. Results: The retention time of gallic acid, curcumin and piperine was found to be 3.3(±0.2), 4.7 (±0.2) and 5.6 (±0.2) min, respectively. The linearity range for gallic acid, curcumin and piperine was found to be 10-70 μg/ml, 20-80 µg/ml and 2-14 µg/ml, respectively with the coefficient of linear regression greater than 0.99 for all markers. Mean percent recoveries for gallic acid, curcumin, and piperine were found within the limit of acceptance (99-100%). The percent relative standard deviation (%RSD) for precision and robustness was found less than 2%, which indicates the method is precise and robust. The developed method applied for quantification of these markers from the marketed ayurvedic formulation of Dekofcyn tablet. Conclusion: The developed method was found to be simple, rapid, precise and reproducible for standardization of Dekofcyn tablet and can be useful for other formulations containing these three markers.

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.

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