scholarly journals Stability-indicating Reversed Phase-Ultra Performance Liquid Chromatography Method Development and Validation for Simultaneous Determination of Encorafenib and Binimetinib in Formulation

2020 ◽  
pp. 488-494
Author(s):  
Taduvai Venkata Raveendranath ◽  
Rajaiah Thangaraj Saravanakumar ◽  
Anjana Male
Keyword(s):  
Method Development ◽  
Detection System ◽  
Ultra Performance Liquid Chromatography ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Liquid Chromatography Method

A simple, accurate and precise stability indicating method was developed for the simultaneous estimation of the encorafenib (ECRB) and binimetinib (BMTB) in a dosage form by UPLC. Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8m) reverse phase column and the mobile phase composition of 0.01N KH2PO4 buffer (3.5 pH) and acetonitrile in the proportion of 55:45 was processed thru a column at a flow rate of 1.0 ml/min. Temperature of the column oven was kept at 30.0°C and the wavelength maximum of detection system was set to 294 nm. Retention times of ECRB and BMTB were found to be 0.767 min and 1.130 min respectively. Repeatability of the method was determined in the form of %RSD and findings were 0.3 and 0.6 for ECRB and BMTB respectively. The percentage recovery of the method was found to be 99.59% and 99.70% for ECRB and BMTB respectively. LOD, LOQ values obtained from regression equations of ECRB and BMTB were 0.51, 1.55mg/ml and 1.47, 4.44 mg/ml respectively. Regression equation of ECRB was y = 6684.x + 18102 and BMTB was y = 13118x + 2159. Two analytes were subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 0.76% and 6.88%. Retention times and total run time of two drugs were decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of ECRB and BMTB.

scholarly journals Stability indicating Ultra Performance Liquid Chromatography method development and validation for simultaneous estimation of artemether and lumefantrine in bulk and pharmaceutical dosage form

2019 ◽  
Vol 9 (2) ◽  
pp. 217-221
Author(s):  
Bandari Sukanya ◽  
V Mohan Goud ◽  
P Anitha
Keyword(s):  
Liquid Chromatography ◽  
Dosage Form ◽  
Method Development ◽  
Ultra Performance Liquid Chromatography ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

Ultra performance liquid chromatography method was developed for the simultaneous estimation of the Artemether (AMT) and Lumefantrine (LFT) in Tablet dosage form. Chromatogram was run through X-bridge C18 100 x 2.1 mm, 3.5m. Mobile phase containing Buffer 0.01N KH2PO4 (3.5pH): Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 0.3ml/min. Buffer used in this method was 0.01N KH2PO4. Temperature was maintained at 30°C. Optimized wavelength selected was 215nm. Retention time of AMT and LFT were found to be 0.787 min and 1.572min. %RSD of the AMT and LFT were and found to be 0.7 and 0.6 respectively. %Recovery was obtained as 99.49% and 100.22% for AMT and LFT respectively. LOD, LOQ values obtained from regression equations of AMT and LFT were 0.03, 0.08 and 0.095, 0.288 respectively. Regression equation of AMT is y = 19308x + 1509 and y = 36919x + 11566 of LFT. The developed method was simple and economical that can be adopted in regular Quality control test in Industries. Keywords: Artemether (AMT), Lumefantrine (LFT), Acetonitrile, UPLC.

scholarly journals Stability-Indicating Method Development and Validation for Simultaneous Estimation of Ombitasvir, Paritaprevir, and Ritonavir in Formulation by Ultra Performance Liquid Chromatography

2020 ◽  
pp. 457-463
Author(s):  
Samudrala Lakshmi Maneka ◽  
Rajaiah Thangaraj Saravanakumar ◽  
Anjana Male
Keyword(s):  
Method Development ◽  
Detection System ◽  
Research Work ◽  
Ultra Performance Liquid Chromatography ◽  
Drug Formulation ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Alkaline Conditions ◽  
Development And Validation

Aim of the present research work was to develop a sensitive, precise and robust stability-indicating UPLC method for the simultaneous estimation of ombitasvir, paritaprevir and ritonavir in formulations. The chromatographic separation of mixture of ombitasvir, paritaprevir and ritonavir was attained in isocratic method utilizing a mobile phase of 0.01N Potassium dihydrogen orthophosphate (pH 5.3) and methanol in the proportion of 60:40%v/v utilizing a BEH C18 column which has dimensions of 100 x 3 mm, 1.7m particle size and the flow rate of 0.3 ml/min. The detection system was monitored at 252nm wavelength maximum with 0.2 ml injection volume. The retaining time for ombitasvir, paritaprevir and ritonavir was achieved at 1.765 min, 2.192 min, and 1.326 min respectively. Ombitasvir, paritaprevir and ritonavir and their combined drug formulation were exposed to thermal, acidic, oxidative, photolytic, and alkaline conditions. The present method was validated as per the guidelines given by the ICH for specificity, accuracy, sensitivity, linearity and precision. The developed method was highly sensitive, rapid, precise and accurate than the earlier reported methods. The total run time was decreased to 3.0 min; hence, the technique was more precise and economical. Stability studies directed for the suitability of the technique for degradation studies of ombitasvir, paritaprevir and ritonavir. The projected method can be utilized for routine analysis in quality control department in pharmaceutical trades.

A NOVEL STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (08) ◽  
pp. 54-61
Author(s):  
B. Venkateswara Rao ◽  
◽  
S. Vidyadhara ◽  
V. Basaveswara Rao
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Liquid Chromatography Method ◽  
Hplc Method Development ◽  
Development And Validation

The prime aim of the present investigation was to develop and validate a novel, precise, accurate, specific, rapid and economical stability- indicating isocratic reverse phase liquid chromatography method for the quantitative simultaneous estimation of valsartan and hydrochlorothiazide in bulk and marketed formulations. Estimation of drugs in this combination was achieved with a C18 column [Kromasil 100-5 C18 column, P134 250 × 4.6 mm] kept at ambient temperature, isocratic mode using mobile phase of composition acetonitrile and phosphate buffer (40:60 V/V, pH 4). The flow rate was 0.8 ml/min and the effluents were monitored at 235 nm, using variable wavelength UV detector. The retention time of valsartan and hydrochlorothiazide were 2.65 min and 3.97 min, respectively. Validation of the method was done according to the ICH guidelines for different analytical parameters. The method was found to be linear over a range of 50-250 μg/mL for valsartan and hydrochlorothiazide. The established method was as reproducible with a %RSD value of less than 2 and having robustness and accuracy within the specified limits. Assay of marketed formulation was determined and was 99.04% and 99.8% respectively. The stressed samples were analyzed. The proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The proposed method can be successfully employed in the estimation of commercial formulations.

scholarly journals Development and Validation of Stability-Indicating Assay Method by RP-HPLC for Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Pharmaceutical Dosage Form

2020 ◽  
Vol 10 (4) ◽  
pp. 79-86
Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Rosuvastatin Calcium

A Simple, precise, and accurate stability-indicating reversed-phase high-performance liquid chromatography method has been established for the simultaneous estimation of rosuvastatin calcium and fenofibrate in combined bulk and tablet formulation. The chromatographic separation was performed on reverse phase Princeton (C18) (250 mm x 4.6 mm, 5µ) column with mobile phase as a mixture of water (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio (40:60) v/v at the flow rate 1.0 ml/min. Detection was carried out at wavelength 240 nm. The retention time under the optimized condition of Rosuvastatin calcium and Fenofibrate was found to be 2.485 & 3.905 minutes respectively. The calibration curve was linear in the range of 6-16 µg/ml and 87-232 µg/ml for rosuvastatin calcium and fenofibrate with a correlation coefficient of 0.9999 and 0.9994 respectively. Relative standard deviation values for all key parameters were less than 2.0%. The percentage recovery was found to be 99.66-100.37% and 99.13-100.44% for rosuvastatin calcium and fenofibrate respectively. The developed reversed-phase high-performance liquid chromatography method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical, and could be used for regular quality control of rosuvastatin calcium and fenofibrate in bulk and tablet formulations.  Keywords: Rosuvastatin calcium, Fenofibrate, RP-HPLC, Method validation, ICH guidelines.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR BY REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND TABLET DOSAGE FORMS

2017 ◽  
Vol 10 (11) ◽  
pp. 59
Author(s):  
Sufiyan Ahmad ◽  
Mohammed Rageeb Mohammed Usman
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

  Objective: A simple rapid, accurate, precise, and reproducible validated reversed-phase high performance liquid chromatography method was developed for the determination of emtricitabine (EMB) and tenofovir (TEN) in bulk and tablet dosage forms.Methods: The quantification was carried out using symmetry Premsil C18 (250 mm×4.6 mm, 5 μm) Younglin (S.K.) gradient way using mobile phase comprising of methanol:water (70:30 v/v) pH 3 and a detection wavelength of 273 nm, and injection volume of 20 μL, with a flow rate of 1 ml/minutes.Results: In the developed method, the retention time of EMB and TEN were found to be 3.1667 minutes and 7.5000 minutes. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines.Conclusion: The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence, the method was found to be simple, accurate, precise, economic, and reproducible. Hence, it is worthwhile that the proposed methods can be successfully utilized for the routine quality control analysis EMB and TEN in bulk drug as well as in formulations.

scholarly journals Method Development and Validation for Simultaneous Estimation of Ketorolac and Sparfloxacin by RP-HPLC

2013 ◽  
Vol 1 (04) ◽  
pp. 95-101 ◽  
Author(s):  
Rahul Singh ◽  
Ashish Pathak ◽  
Pooja Chawla
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Sample Volume ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Mobile Phase Flow Rate ◽  
Pharmaceutical Dosage Forms ◽  
Liquid Chromatography Method

A modified simple, selective, rapid, precise reversed phase high performance liquid chromatography method has been developed and validated for the simultaneous estimation of ketorolac and sparfloxacin. The separation was made in a Hypersil-Keystone C-18 column using a methanol: water (60:40, v/v) (pH 3.1) as mobile phase at 308 nm. The mobile-phase flow rate and the sample volume injected were 0.9 ml/min and 20 μl, respectively. Retention time of sparfloxacin and ketorolac was found to be 3.181 and 4.473 minutes respectively. The correlation coefficient of both drugs was found to be 0.999. The accuracy of ketorolac was found to be 99.82% - 100.55% whereas for sparfloxacin, it was 99.76% - 99.89%. Over all % RSD was found to be less than 2%. The method was validated according to ICH guidelines with respect to linearity, accuracy, precision, robustness, specificity, etc. The developed method can be used for routine analysis of ketorolac and sparfloxacin in their pharmaceutical dosage forms.

A NOVEL STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF NEBIVOLOL AND INDAPAMIDE IN BULK AND PHARMACEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (09) ◽  
pp. 67-73
Author(s):  
B. Venkateswara Rao ◽  
◽  
S. Vidyadhara ◽  
A. Ramu ◽  
N. Sai Prudhvi ◽  
...  
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Liquid Chromatography Method ◽  
Hplc Method Development ◽  
Liquid Chromatographic

A simple, precise, accurate, reproducible and economical stability- indicating reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of nebivolol and indapamide in bulk and marketed formulations. Estimation of drugs in this combination was done with a C18 column [Kromasil column. 250mm × 4.5 mm] using mobile phase of composition acetonitrile and phosphate buffer (60:40 V/V, pH 3). The flow rate was 0.8 ml/min and the effluents were monitored at 226nm. The retention time of nebivolol and indapamide were 2.9 min and 4.2 min, respectively. The method was found to be linear over a range of 10-50 μg/mL for nebivolol and 2-10 μg/mL for indapamide. The established method proved as reproducible one with a % RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and found to be 99.08% and 99.87% for nebivolol and indapamide, respectively. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist.

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