scholarly journals NEW VALIDATED METHOD FOR THE ESTIMATION OF ALLANTOIN AND PERMETHRIN USIGN RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM

2021 ◽  
pp. 216-222
Author(s):  
MADHAVI S. ◽  
CHALLA SUDHEER REDDY ◽  
B. TIRUMALESWARA RAO
Keyword(s):  
Method Validation ◽  
Quantitative Methods ◽  
Hplc Method ◽  
Allowable Limit ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Ingredients ◽  
Ich Guidelines ◽  
Test Concentration ◽  
Liquid Chromatography Method

Objective: Special, effective high pressure liquid chromatography method has been developed for the simultaneous quantification of Allantoin and Permethrin. Methods: By using Waters HPLC e-2695 quaternary pump with a PDA detector of 2998 instrument the chromatographic separation of Allantoin and Permethrin was achieved on the column of Symmetry C18 (150x4.6 mm, 3.5 µm) using an isocratic elution with a buffer containing 0.1percent ortho phosphoric acid and acetonitrile at a rate of 40:60 as a mobile phase with a flow rate of 1 ml/min at ambient temperature. A detector wavelength of 226 nm utilizing the PDA detector were given in the instrumental settings. The linearity was studied between the concentration range of 1-15 µg/ml of Allantoin and 25-375 µg/ml of Permethrin were injected with a run time of 6 min. As a part of method validation the parameters like specificity, linearity, accuracy, ruggedness, robustness were determined and the results were found to be within the allowable limit. Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines. Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The plotted calibration curves were linear with a regression coefficient of R2>0.999, indicates that the linearity was with in the limit. As a part of method validation the parameters like specificity, linearity, accuracy, ruggedness, robustness were determined and the results were found to be within the allowable limit. Conclusion: The method developed was found to be applicable to routine analysis and to be used for the measurement of both active pharmaceutical ingredients (i. e, Allantoin and Permethrin). Since, there is no HPLC method reported in the literature for the estimation of Allantoin and Permethrin, there is a need to develop quantitative methods under different conditions to achieve improvement in specificity, selecivity etc.

scholarly journals New Validated Method for the Estimation of Pioglitazone and Rosiglitazone Using RP-HPLC

2021 ◽  
pp. 254-262
Author(s):  
Syed Rafi ◽  
Kantipudi Rambabu
Keyword(s):  
Quantitative Methods ◽  
Regression Coefficient ◽  
Hplc Method ◽  
Active Pharmaceutical Ingredients ◽  
Allowable Limit ◽  
Chromatography Method ◽  
Pharmaceutical Ingredients ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Liquid Chromatography Method

New, simple and economical high pressure liquid chromatography method has been developed for the simultaneous quantification of Pioglitazone and Rosiglitazone.By using Waters HPLC e-2695 quaternary pump with a PDA detector of 2998 instrument the chromatographic separation of Pioglitazone and Rosiglitazone was achieved on the column of Inertsil ODS (150x4.6mm, 3.5 µ) using an isocratic elution with a buffer containing 0.1percentformic acid and acetonitrile at a rate of 30:70 as a mobile phase with a flow rate of 1 ml/min at ambient temperature. A detector wavelength of 261 nm utilizing the PDA detector were given in the instrumental settings. The linearity was studied between the concentration range of 3-45 µg/ml of Pioglitazone and 1-15 µg/ml of Rosiglitazone were injected.The plotted calibration curves were linear with a regression coefficient of R2> 0.999, indicates that the linearity was with in the limit. As a part of method validation the parameters like specificity, linearity, accuracy, ruggedness, robustness were determined and the results were found to be within the allowable limit. The method developed was found to be applicable to routine analysis and to be used for the measurement of both active pharmaceutical ingredients (i.e, Pioglitazone and Rosiglitazone).Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines. Since, there is no HPLC method reported in the literature for the estimation of Pioglitazone and Rosiglitazone, there is a need to develop quantitative methods under different conditions to achieve improvement in specificity, selecivity etc.

scholarly journals STABILITY INDICATIVE AND COST EFFECTIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FAVIPIRAVIR AND PERAMIVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

2021 ◽  
pp. 265-271
Author(s):  
SRINIVAS LINGABATHULA ◽  
NEELU JAIN
Keyword(s):  
Method Development ◽  
Cost Effective ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Ingredients ◽  
Related Substances ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Test Concentration ◽  
Development And Validation

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Favipiravir and Peramivir and their related substances. Methods: A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Favipiravir and Peramivir. The chromatographic strategy utilized Inertsil ODS column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent orthophosphoric acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 260 nm utilizing the PDA detector was given in the instrumental settings. Using the impurity-spiked solution, the chromatographic approach was streamlined. Results: Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. LOD and LOQ for the two active ingredients and their impurities were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, which means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness was determined as a part of method validation and the results were found to be within the acceptable range. Conclusion: The proposed method to be fast, simple, feasible and affordable in RS condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.

scholarly journals NEW STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF CAPECITABINE AND DOCETAXEL IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

2021 ◽  
pp. 177-182
Author(s):  
NEEHARIKA TIRUMALASETTY ◽  
RAMCHANDRAN D.
Keyword(s):  
Method Development ◽  
Hplc Method ◽  
Assay Condition ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Ingredients ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Test Concentration ◽  
Development And Validation

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Capecitabine and Docetaxel. Methods: A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Capecitabine and Docetaxel. The chromatographic strategy utilized Inertsil ODS column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and water (50:50). A flow rate of 1 ml/min and a detector wavelength of 220 nm utilizing the PDA detector were given in the instrumental settings. Using the impurity-spiked solution, the chromatographic approach was streamlined. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. Results: LOD and LOQ for the two active ingredients and their impurities were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.

scholarly journals DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RELATED SUBSTANCES OF TRANDOLAPRIL BY RP-HPLC AND ITS DEGRADATION

2021 ◽  
pp. 115-121
Author(s):  
CHALLA SUDHEER REDDY ◽  
B. TIRUMALESWARA RAO
Keyword(s):  
Quantitative Methods ◽  
Gradient Elution ◽  
Hplc Method ◽  
Allowable Limit ◽  
Stability Indicating ◽  
Pharmaceutical Ingredients ◽  
Related Impurities ◽  
Related Substances ◽  
Rp Hplc ◽  
Test Concentration

Objective: A validated stability-indicating RP-HPLC method for Trandolapril was developed by separating its related impurities. Methods: By using Waters HPLC e-2695 quaternary pump with a PDA detector of 2998 instrument the chromatographic separation of Trandolapril and its related impurities was achieved on the column of Agilent eclipse C18 (150x4.6 mm, 3.5 µ) using gradient elution with a buffer containing 0.1percent formic acid and acetonitrile as a mobile phase with a flow rate of 1 ml/min at ambient temperature. A detector wavelength of 213 nm utilizing the PDA detector were given in the instrumental settings. The linearity was studied between the concentration range of 4-60 µg/ml of Trandolapril and 0.5-7.5 µg/ml of imp-E, imp-A, imp-B and 0.7-10.5 µg/ml of imp-D were injected with a run time of 17 min. Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines. Results: LOD and LOQ for the Trandolapril and its impurities were established with respect to test concentration. The plotted calibration curves were linear with a regression coefficient of R2>0.999, indicates that the linearity was with in the limit. As a part of method validation the parameters like specificity, linearity, accuracy, ruggedness, robustness were determined and the results were found to be within the allowable limit. Conclusion: The method developed was found to be applicable to routine analysis and to be used for the measurement of active pharmaceutical ingredients (i. e, Trandolapril and its related impurities). Since, there is no HPLC method reported in the literature for the estimation of Trandolapril and its related impurities, there is a need to develop quantitative methods under different conditions to achieve improvement in specificity, selecivity etc.

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE IN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 35-40
Author(s):  
A. S. Bagde ◽  
V. V. Khanvilkar ◽  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Dextromethorphan Hydrobromide

The present work describes a validated reverse phase high performance liquid chromatography (RPHPLC) method for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate in pharmaceutical dosage from. The drugs were resolved using Hemochrom Intsil C18-5U column (250×4.6) mm in isocratic mode with mobile phase methanol: water (0.08% diethylamine, 0.02% of glacial acetic acid and pH 4.4 adjusted with orthophosphoric acid) in the ratio of 70:30 V/V at a flow rate of 1.0 mL/min. Retention time of dextromethorphan hydrobromide and quinidine sulphate were 4.9±0.2 and 3.6±0.2, respectively, at 292nm. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines. Linear responses were obtained in concentration ranges of 5-35 μg/mL for dextromethorphan hydrobromide and 4-16 μg/mL for quinidine sulphate, with correlation coefficient (r2) of 0.999 for both the drugs. A simple, selective, accurate, precise, robust and reliable RP-HPLC method thus developed and validated for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate.

LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION OF RELATED IMPURITIES OF LURASIDONE AND ITS FORMULATION

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (09) ◽  
pp. 41-48
Author(s):  
R. N Kachave ◽  
◽  
P. B. Mandlik ◽  
S. R. Nisal
Keyword(s):  
Method Development ◽  
Gradient Elution ◽  
Hplc Method ◽  
Chromatography Method ◽  
Related Impurities ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
The Stability ◽  
Development And Validation

An RP-HPLC method was developed for the quantification of related impurities of lurasidone and its formulation. The chromatographic separation employs gradient elution using an Inertsil ODS C18 (150x4.6) mm, 5μm columns. Mobile phase consisting of solvent A-buffer (pH 3.0): methanol (90:10 %v/v) and solvent B-acetonitrile: water (80:20 % v/v) delivered at a flow rate of 1.0 mL/min. The analytes were detected and quantified at 210 nm using PDA. The method was validated as per ICH guidelines, demonstrating to be a simple, precise, selective, linear and accurate within the corresponding range of impurities of lurasidone. Linearity was observed in the concentration range of 2-6 µg/mL. The RT for Lurasidone was about 18.5 min and three known impurities at RRT about 0.15, 0.21 and 0.36. The specificity of the method was investigated under different stress conditions including hydrolytic, oxidative, photolytic and thermal as recommended by ICH guidelines. Relevant degradation was found to take place under oxidative conditions. Degradation impurities did not interfere with the RT of drug. The peak purity obtained with the aid of PDA detection and satisfactory resolution between related impurities established the specificity of the determination. All these results provide the stability indicating capability of the method.

scholarly journals Simultaneous Estimation and Validation of Atorvastatin Calcium and Aspirin in Combined Capsule Dosage Form by RP HPLC Method

2012 ◽  
Vol 9 (3) ◽  
pp. 1449-1456
Author(s):  
B. V. Suma ◽  
K. Kannan ◽  
V. Madhavan ◽  
Chandini R. Nayar
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Limit Of Quantification ◽  
Chromatography Method ◽  
Atorvastatin Calcium ◽  
Ich Guidelines ◽  
Phase Liquid ◽  
Liquid Chromatography Method

A new simple, specific, precise and accurate revere phase liquid chromatography method has been developed for estimation of atorvastatin calcium (AST) and ASPIRIN (ASP) simultaneously in a combined capsule dosage forms. The chromatographic separation was achieved on a 5 – micron C 18 column (250x 4.6mm) using a mobile phase consisting of a mixture of Acetonitrile: Ammonium Acetate buffer 0.02M (68:32) pH 4.5. The flow rate was maintained at 0.8 ml/min. The detection of the constituents was done using UV detector at 245 nm for AST and ASP. The retention time of AST and ASP were found be 4.5915 ± 0.0031 min and 3.282 ±0.0024 min respectively. The developed method was validated for accuracy, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ) and robustness as per the ICH guidelines.

scholarly journals Research Article on Development and Validation of RP-HPLC Method for Estimation of Canagliflozin

2019 ◽  
Vol 11 (02) ◽  
pp. 85-92
Author(s):  
Gudipally. Mounika ◽  
K. Bhavya Sri ◽  
R. Swethasri ◽  
M. Sumakanth
Keyword(s):  
Retention Time ◽  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Validation Parameters ◽  
Liquid Chromatography Method ◽  
Development And Validation

To develop an accurate, precise, specific high performance liquid chromatography method for quantification of Canagliflozin in bulk and dosage forms. A C18 column (250mm X 4.6mm; 5μm phenomenex) was used with mobile phase containing Acetonitrile-0.1% sodium acetate buffer (pH-4.6), (20:80) in isocratic mode. The flow rate maintained was 1.0ml/min and the U.V detector was operated at 291nm. The retention time of Canagliflozin was 3.307min and showed a good linearity in concentration range of 2-14μg/ml with correlation coefficient of 0.999. The average percent recovery was found to be 99.98%. The developed method follows validation parameters such as system suitability, linearity, precision, accuracy, limit of detection and limit of quantification and robustness as per ICH guidelinesQ2(R1). The proposed method was found to provide faster retention time with sharp resolution with linearity at a lowest concentration as compared to previous methods and this method is validated as per International conference on harmonization guidelines and successfully applied for bulk and pharmaceutical dosage form.

scholarly journals Method Development and Validation of Salmeterol xinofoate by HPLC

2021 ◽  
Vol 6 (6) ◽  
pp. 52-63
Author(s):  
Sahebrao H. Shembade ◽  
Sagar S. Landage ◽  
Ashapak M. Tamboli ◽  
Ritesh S. Bhate ◽  
Kaustubh V. Gavali ◽  
...  
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Chromatography Method ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
Development And Validation

A rapid and precise high performance liquid chromatography method has been developed for the validation of Salmeterol xinofoate in its pure dosage form. The separation was carried out on Agilent Zorbax Bonus RP- (250mm ×4.6mm 5μ) column with a mobile phase consisting of 0.1% Formic acid: Acetonitrile in the ratio of 64:36 v/v as a mobile phase and flow rate is 1ml/min. The detection was carried out at wavelength 234nm. The column thermostatically controlled at 30℃. The retention time of Salmeterol was found to be 1.96 min. The Salmeterol xinofoate followed linearity in the concentration range of 40-60μg/mL with r2= 0.999. The developed method was validated for sensitivity, accuracy and precision. The sample was scanned from 200- 400nm with PDA detector. The % recovery of sample was found to be. The LOD and LOQ of the Salmeterol xinofoate was found to be 2.67μg/ml and 8.08μg/ml respectively. The suitability of this HPLC method for quantitative estimation of Salmeterol xinofoate was proved by validation by the requirements of ICH guidelines.

scholarly journals STABILITY INDICATIVE AND COST EFFECTIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FENOFIBRIC ACID AND PITAVASTATIN BY USING RP-HPLC

2021 ◽  
pp. 292-297
Author(s):  
D. RAMCHANDRAN ◽  
ANITHA KETHIPALLI ◽  
MANNAM KRISHNAMURTHY
Keyword(s):  
Method Development ◽  
Cost Effective ◽  
Hplc Method ◽  
Fenofibric Acid ◽  
Assay Condition ◽  
Pharmaceutical Ingredients ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Test Concentration ◽  
Development And Validation

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Fenofibric acid and Pitavastatin. Methods: A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Fenofibric acid and Pitavastatin. The chromatographic strategy utilized X-bridge phenyl column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (60:40). A flow rate of 1 ml/min and a detector wavelength of 242 nm utilizing the PDA detector were given in the instrumental settings. Results: Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drugs.

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