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.

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 STABILITY INDICATING AND COST-EFFECTIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SOTORASIB BY USING RP-HPLC

2021 ◽  
pp. 154-159
Author(s):  
SUBBA RAO YARLAGADDA ◽  
SUBBA RAO MANNAM ◽  
BABY PADMINI JAMPANI
Keyword(s):  
Method Development ◽  
Cost Effective ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Assay Condition ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Test Concentration ◽  
Method Development And Validation ◽  
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 ingredient of Sotorasib. Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Sotorasib. The chromatographic strategy utilized symmetry C18 column of dimensions 150x4.6 mm, 3.5 µ, using isocratic elution with a mobile phase of acetonitrile and 0.1% orthophosphoric acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 221 nm utilizing the PDA detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. Results: LOD and LOQ for the active ingredient were established with respect to test concentration. The calibration chart plotted was 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 drug.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF TIVOZANIB BY USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM

2021 ◽  
pp. 199-205
Author(s):  
T. JAISON JOSE ◽  
Y. SUBBAREDDY ◽  
K. SANKAR
Keyword(s):  
Method Development ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Assay Condition ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Test Concentration ◽  
Method Development And Validation ◽  
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 ingredient of Tivozanib. Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Tivozanib. The chromatographic strategy utilized X-bridge phenyl column of dimensions 150x4.6 mm, 3.5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (50:50). A flow rate of 1 ml/min and a detector wavelength of 216 nm utilizing the PDA detector were given in the instrumental settings. 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 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.

scholarly journals STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF MITOMYCIN AND FLUOROURACIL BY USING UPLC

2021 ◽  
pp. 236-243
Author(s):  
GUNTURU RAVITEJA ◽  
KANTIPUDI RAMBABU
Keyword(s):  
Method Development ◽  
Assay Condition ◽  
Pharmaceutical Ingredients ◽  
Stability Indicating Method ◽  
Ich Guidelines ◽  
Test Concentration ◽  
Method Development And Validation ◽  
Development And Validation

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable UPLC method for the measurement of active pharmaceutical ingredients of Mitomycin and Fluorouracil. Methods: A simple, selective, validated and well-defined stability that shows isocratic UPLC methodology for the quantitative determination of Mitomycin and Fluorouracil. 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 formic acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 255 nm utilizing the PDA detector was given in the instrumental settings. 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 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 RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

Stability Indicating RP-HPLC Method Development and Validation for the Determination of Solifenacin Succinate in Bulk and its Pharmaceutical Formulation

2021 ◽  
pp. 3509-3514
Author(s):  
A. Tanuja ◽  
S. Ganapaty ◽  
Varanasi S N Murthy
Keyword(s):  
Method Development ◽  
Current Method ◽  
Hplc Method ◽  
Pharmaceutical Ingredients ◽  
Solifenacin Succinate ◽  
Ich Guidelines ◽  
Degradation Studies ◽  
Hplc Method Development ◽  
Development And Validation

The current work aims to establish a novel and advanced reverse phase isocratic liquid chromatography system followed by validation and to conduct stability analysis in active pharmaceutical ingredients and formulations for the quantification of Solifenacin Succinate. The optimized elution was achieved with column Sunfire C8 (4.6 x 150mm, 5µm), using the mobile phase of Buffer: Methanol: Acetonitrile in the composition ratio of 45:45:10 v/v. The wavelength of detection was selected as 220nm with 1.0ml/ min flow rate and 30μl injection volume. The retention time of Solifenacin Succinate was found 2.94 min respectively. The method developed has been validated for various analytical parameters according to ICH guidelines. The Linearity was attained at 20 to100 μg/ml of concentration range. The established method was proved as reproducible. The Assay was obtained as 100.40%. The degradation studies were carried out at all degradative conditions and the results of degradation studies denote that the current method was specific, reliable, and economical. Hence, the developed method can be applied for the qualitative and quantitative determination of the selected drug and its commercial formulations.

scholarly journals RP-HPLC Method Development and Validation for Simultaneous Estimation of Clarithromycin and Paracetamol

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Sadana Gangishetty ◽  
Surajpal Verma
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Development And Validation

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of clarithromycin (CLA) and paracetamol (PCM). C18 column (Kromasil ODS, 5 µm, 250 × 4.6 mm) and a mobile phase containing phosphate buffer (0.05 M) along with 1-octane sulphonic acid sodium salt monohydrate (0.005 M) adjusted to pH 3.2: acetonitrile (50 : 50 v/v) mixture was used for the separation and quantification. The flow rate was 1.0 mL/min and the eluents were detected by UV detector at 205 nm. The retention times were found to be 2.21 and 3.73 mins, respectively. The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75–175 µg/mL for both drugs. The developed method was applied successfully for assay of clarithromycin and paracetamol in their combined in-house developed dosage forms and in vitro dissolution studies.

scholarly journals Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

2020 ◽  
Vol 10 (4) ◽  
pp. 97-101
Author(s):  
Mithun Rudrapal ◽  
Nazim Hussain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Average Percentage ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

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.

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