Method development and validation of Ifetroban by RP-UPLC

2020 ◽  
Vol 11 (3) ◽  
pp. 3158-3163
Author(s):  
Bharani Pandilla ◽  
Chitra K ◽  
Nalini C N ◽  
Ashok P ◽  
Vadivelan R
Keyword(s):  
Method Development ◽  
Active Pharmaceutical Ingredient ◽  
Ultra Performance Liquid Chromatography ◽  
Precise Determination ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Triethyl Amine ◽  
Method Development And Validation ◽  
Drug Purity ◽  
Development And Validation

The purpose of this work is to develop and validate reverse phase Ultra performance liquid chromatography (UPLC) method for the rapid and precise determination of ifetroban sodium in its pure form and in formulations. A simple, specific, accurate, precise isocratic UPLC method for analysis of Ifetroban sodium was developed and validated using a Phenomenex C18 column (50 mm x 3.0 mm, 3µ) as the stationary phase, in conjunction using Triethyl amine buffer: methanol in the proportion of 25:75 with a flow rate of 1.0 mL/min, run time is 3 min and UV detector is used at 235 nm wavelength. The developed UPLC technique was found to be rapid as the retention time was 0.56 minutes for Ifetroban peak to elute. The developed UPLC technique was validated as per the ICH guidelines for specificity, linearity, accuracy, precision, robustness and found to be satisfactory. Linearity was established in the concentration range 100-300 µg/mL with correlation coefficient of 0.998 and the equation obtained is y = 0.635x + 0.639.The percentage recovery is 100.41. The method is rugged and is trouble free and transferable. The study showed that the developed UPLC technique can be used for the estimation of drug purity, stability, solubility and with no interference of pharmaceutical excipients from the active pharmaceutical ingredient. The precision, accuracy, robustness results obtained enables rapid quantification of ifetroban for quantitative analysis.

scholarly journals Method development and validation of droxidopa by HPLC technique

2020 ◽  
Vol 11 (4) ◽  
pp. 6227-6232
Author(s):  
Bharani Pandilla ◽  
Chitra K ◽  
Nalini C N ◽  
Ashok P
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Precise Determination ◽  
Graphic System ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Technique ◽  
Development And Validation

The purpose of this work is to develop and validate stability, indicating reverse phase High-performance liquid chromatography (HPLC) method for the rapid and precise determination of droxidopa in its pure form and formulations. A simple, fast, accurate and economical way has been developed and validated for the quantification of droxidopa by HPLC technique. The chromato graphic system was equipped with Shimpack columnC18((250x 4.6) mm, 5µ) as stationary phase and UV detector at 220 nm, in conjunction with a mobile phase of phosphate buffer pH 2.0:acetonitrile (60:40,% v/v) at a flow rate of 1.0 mL/min. The developed HPLC technique was found to be rapid as the retention time was 2.2 minutes for droxidopa peak to elute. The method was validated as per the International Conference on Harmonization (ICH) guidelines for specificity linearity, accuracy, precision. The developed method was selective with well-resolved peak. Linearity was observed over the concentration range of 25-150µg/mL for droxidopa. The recovery of Droxidopa was found to be 100.54% - 101.65%. Statistical techniques were employed for the validation of precision, linearity, accuracy, robustness and ruggedness and can be applied for routine analysis. Validation revealed that the developed method was specific, accurate, precise, reliable, robust, reproducible and suitable for the systematic quantitative review.

scholarly journals Analytical Method Development and Validation of Solifenacin in Pharmaceutical Dosage Forms by RP-HPLC

2014 ◽  
Vol 2014 ◽  
pp. 1-5
Author(s):  
Rihana Parveen Shaik ◽  
Srinivasa Babu Puttagunta ◽  
Chandrasekar Kothapalli Bannoth ◽  
Bala Sekhara Reddy Challa
Keyword(s):  
Method Development ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Uv Detector ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Phase Combination ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A new, accurate, precise, and robust HPLC method was developed and validated for the determination of solifenacin in tablet dosage form. The chromatographic separation was achieved on an Inertsil ODS 3V C18 (150 mm × 4.6 mm, 5 μm) stationary phase maintained at ambient temperature with a mobile phase combination of monobasic potassium phosphate (pH 3.5) containing 0.1% triethylamine and methanol (gradient mode) at a flow rate of 1.5 mL/min, and the detection was carried out by using UV detector at 220 nm. The performance of the method was validated according to the present ICH guidelines.

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.

Simultaneous HPLC Method Development and Validation of Bilastine and Montelukast in Bulk and Formulation

2021 ◽  
pp. 6061-6065
Author(s):  
Ankita Shinde ◽  
G.B. Gajeli ◽  
Sneha Ubale ◽  
Vinod Matole
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Tablet Formulations ◽  
Hplc Method Development ◽  
Development And Validation

A new, simple, rapid, selective, precise and accurate reverse phase high performance liquid chromatography assay has been developed for simultaneous estimation of Bilastine, and Montelukast in tablet formulations. The separation was achieved by using Phenomenax Kinetex XB C-18 column (150 x 4.6mm, 5 .) using mobile phase Methanol: 0.1% TFA water (80:20). Injection volume was 10µl. The flow rate was 1.0mL.min-1 and the separated drugs were detected using UV detector at the wavelength of 270nm. The retention time of Bilastine and Montelukast was noted to be 1.27, and 4.86 respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations containing any one of the above drugs, or a combination, without any alteration in the chromatographic conditions.

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 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.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF COMBINATION OF ANTI-ASTHMATIC DRUGS MONTELUKAST AND DOXOFYLLINE

2021 ◽  
Vol 11 (6) ◽  
pp. 86-91
Author(s):  
Sachin N. Kapase
Keyword(s):  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Analytical Techniques ◽  
Ultra Performance Liquid Chromatography ◽  
Hplc Method ◽  
Uv Spectrophotometry ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Layer Chromatography

For qualitative and quantitative analysis, various analytical techniques are available such as Ultraviolet (UV) Spectrophotometry, High-performance liquid chromatography (HPLC), High-performance thin layer chromatography (HPTLC). As per literature survey, there are some UV, HPLC, Ultra-Performance Liquid Chromatography (UPLC) and HPTLC analytical methods are developed for Montelukast and Doxofylline individually and in a combination with other drugs too, since yet there are no significant stability studies indicating HPLC method reported for Montelukast and Doxofylline combinations. In the current study, the HPLC method is developed and validated for simultaneous quantitative estimations of Montelukast and Doxofylline. These present techniques are more efficient and sensitive as compared to other analytical techniques.

Analytical Method Development and Validation of Glipizide to Determine Residual solvents by head Space-Gas Chromatography

2021 ◽  
pp. 2440-2444
Author(s):  
Sanapala Srinivasa Rao ◽  
A. Vijayalakshmi
Keyword(s):  
Gas Chromatography ◽  
Method Development ◽  
Limit Of Detection ◽  
Dimethyl Formamide ◽  
Analytical Methodology ◽  
Residual Solvents ◽  
Flame Ionization ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

Residual solvents in Pharmaceuticals are termed as organic volatile impurities. These are the chemicals that are used in the manufacture of drug substance or excipients or use in the preparation of final formulation. Most of the available methods use liquid chromatography which could be expensive and time consuming. Hence, an analytical methodology was developed for the quantification of residual solvents in Glipizide using a headspace gas chromatography (HSGC) with the help of flame ionization detector (FID). Methanol, acetone and dimethyl formamide as residual solvents were determined in Glipizide. Analysis was performed by headspace GC/FID method on Auto system- HS40. Nitrogen was used as a carrier gas and the separation of residual solvents was achieved by DB-Wax 0.25mm, 0.3mcm column. The thermostat temperature was 115 °C for 40 minutes for each vial. % RSD for nine injections obtained are in acceptance criteria. The correlation coefficient R2 obtained greater than 0.99. The method parameters were validated includes specificity, limit of detection and quantification, accuracy, linearity, precision, and robustness. According to the International Conference on Harmonization (ICH) guidelines, a new simple, specific, accurate and precise method was developed and validated.

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