scholarly journals Development and Validation of a Versatile UPLC-PDA Method for Simultaneous Determination of Paracetamol, Tizanidine, Aceclofenac, and Nimesulide in Their New Combinations

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Sami Bawazeer ◽  
Khalid M. Badr El-Din ◽  
Ahmed M. Abdel-Megied
Keyword(s):  
Limit Of Detection ◽  
Dosage Forms ◽  
New Combination ◽  
Development Method ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Acquity Uplc ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, and validated UPLC method was developed for the simultaneous quantitation of paracetamol (PAR), tizanidine (TIZ), aceclofenac (ACF), and nimesulide (NIM) either in pure forms or in their different tablet dosage forms. Chromatographic separation was attained on an ACQUITY UPLC™ BEH C18 column (100 mm × 2.1 mm, 1.7 μm) with a mobile phase consisting of 20 mM phosphate buffer (pH 7.0) : acetonitrile in the proportion (60 : 40 v/v) isocratically pumped at a flow rate of 1.25 mL·min−1, and detection was monitored at 305 nm. All analytes were separated simultaneously at a retention time (tr) of 1.42, 2.31, 3.63, and 5.62 min for PAR, TIZ, ACF, and NIM, respectively, with a total run time less than 6.0 min. The proposed method was validated according to ICH guidelines with respect to accuracy, precision, linearity, limit of detection, limit of quantitation, and robustness. Linearity was obtained over a concentration range of 81.25–487.5, 0.5–3.5, 25–150, and 25–150 µg·mL−1 for PAR, TIZ, ACF, and NIM, respectively. The development method can be successfully employed in QC laboratories for the routine analysis of the investigated drugs in their new combination.

scholarly journals DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FEBUXOSTAT FOR CONDUCTING IN-VITRO QUALITY CONTROL TESTS IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 11 (9) ◽  
pp. 115
Author(s):  
Jaspreet Kaur ◽  
Daljit Kaur ◽  
Sukhmeet Singh
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation

Objective: A simple, accurate, and selective ultraviolet-spectrophotometric method has been developed for the estimation of febuxostat in the bulk and pharmaceutical dosage forms.Method: The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The developed method was validated statistically with respect to linearity, range, precision, accuracy, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and recovery. Specificity of the method was demonstrated by applying different stressed conditions to drug samples such as acid hydrolysis, alkaline hydrolysis, oxidative, photolytic, and thermal degradation.Results: The study was conducted using phosphate buffer pH 6.8 and λmax was found to be 312 nm. Standard plot having a concentration range of 1–10 μg/ml showed a good linear relationship with R2=0.999. The LOD and LOQ were found to be 0.118 μg/ml and 0.595 μg/ml, respectively. Recovery and percentage relative standard deviations were found to be 100.157±0.332% and <2%, respectively.Conclusion: Proposed method was successfully applicable to the pharmaceutical formulations containing febuxostat. Thus, the developed method is found to be simple, sensitive, accurate, precise, reproducible, and economical for the determination of febuxostat in pharmaceutical dosage forms.

scholarly journals Development and Validation of UV-Spectrophotometric and HPLC Method determination of Dofetilide in Formulation

2020 ◽  
Vol 13 (2) ◽  
pp. 60-70
Author(s):  
Harsha Dhurve ◽  
Yasmini Parshuramkar ◽  
Milind Umekar ◽  
Krishna Gupta
Keyword(s):  
Detection Limit ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Label Claim ◽  
Photodiode Array ◽  
Development And Validation ◽  
Good Agreement

A new, simple, specific and economic UV Spectrophotometric method and HPLC method for the estimation of Dofetilide content in bulk and laboratory prepared mixture. UV spectrophotometric detection was carried out at absorption maxima (λmax) at 231nm using methanol as a solvent. The quantitation of drug was carried out using A1% 1cm at 231nm and Beer’s law was obeyed in the concentration range of 2.5-20 μg/ml, with correlation coefficient value less than 1.The chromatographic separation was carried on a C-18 (250 mm × 4.6 mm, 5μ) column using an isocratic mode with a mixture of Acetonitrile:Phosphate Buffer (pH-7) in the ratio of 55:45% v/v as a mobile phase. The flow rate was 1.5ml/min, temperature is maintained at ambient and detection was made at 231 nm using Photodiode array (PDA) detector. The developed method was validated according to ICH guidelines and different analytical parameters such as linearity, precision, accuracy, specificity, limit of detection, limit of quantitation were determined. The percent amount of drug estimated was nearly 100%, found to be a good agreement with label claim of prepared laboratory mixture. The proposed method was validated for its accuracy, precision, robustness, ruggedness, linearity, limit of detection, limit of quantitation and was found to be in range (% RSD<2.0 and SD <±2.0). Both methods were validated and found to be simple, sensitive, accurate, and precise. The results of the study and statistical data proved the applicability of the present method in routine analysis of Dofetilide in bulk as well as laboratory prepared mixture.

scholarly journals HPLC determination of Escitalopram in tablet dosage forms

Pharmacia ◽  
2022 ◽  
Vol 69 (1) ◽  
pp. 21-24
Author(s):  
Stefan Balkanski
Keyword(s):  
Mobile Phase ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Phase Liquid ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Purpose: A simple, specific, precise, and accurate reversed phase liquid chromatographic (RP-LC) method has been developed for the determination of Escitalopram in tablet dosage form. Methods: The chromatographic separation was achieved on a LiChrosorb C18, 250 mm x 4.6 mm, 5 μm column at a detector wavelength of 270 nm and a flow rate of 1.0 ml/min. The mobile phase was composed of methanol, acetonitrile (70:30 v/v). The retention time of Escitalopram was 5.49 min. The method was validated for the parameters like specificity, linearity, precision, accuracy, limit of quantitation and limit of detection. Results: The method was found to be specific as no other peaks of impurities and excipients were observed. The square of correlation coefficient (R2) was 0.9999 while relative standard deviations were found to be &lt;2.0%. Conclusion: The proposed RP-LC method can be applied for the routine analysis of commercially available formulations of Escitalopram.

DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC Q-ABSORBANCE RATIO METHOD FOR SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND ACECLOFENAC IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (11) ◽  
pp. 50-56
Author(s):  
M. Simoes ◽  
◽  
L. Almeida
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Ratio Method ◽  
Simultaneous Estimation ◽  
Absorbance Ratio ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method has been developed for the simultaneous estimation of eperisone hydrochloride and aceclofenac in combined dosage form. The solvent used was methanol:water (70:30 v/v). The iso-absorptive point was found to be 269.5 nm. Calibration curves were linear over a concentration range of 6-21 μg/ml for eperisone hydrochloride and 8-28 μg/mL for aceclofenac, respectively. The developed method was validated as per International Conference on Harmonization (ICH) guidelines for various parameters such as linearity, precision, accuracy, limit of detection and limit of quantitation. Accuracy of method was determined through recovery studies which were found to be 99.0% - 100.89 % for eperisone hydrochloride and 98.67% - 100.44 % for aceclofenac. Method was found to be reproducible with relative standard deviation (RSD) for intra-and inter-day precision less than 2% over the concentration range. The proposed method can be used for routine analysis of eperisone hydrochloride and aceclofenac in bulk and tablet dosage form.

scholarly journals DEVELOPMENT AND VALIDATION OF HPLC-DAD METHOD FOR THE DETERMINATION OF BISOPROLOL IN TABLET DOSAGE FORMS

2017 ◽  
Vol 9 (6) ◽  
pp. 54 ◽  
Author(s):  
Yuliya Kondratova ◽  
Liliya Logoyda ◽  
Yuliia Voloshko ◽  
Ahmed Abdel Megied ◽  
Dmytro Korobko ◽  
...  
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Label Claim ◽  
Development And Validation ◽  
Tablet Dosage

Objective: A rapid, simple and sensitive RP-HPLC method was developed and validated for the determination of bisoprolol fumarate in bulk and pharmaceutical dosage form.Methods: Chromatographic separation was achieved within 2.5 min on ACQUITY Arc System, Waters Symmetry C18 column (3.9 mm i.d. X 150 mm, 5 μm particle sizes) using a mobile phase consisted of acetonitrile: phosphate buffer (25:75 v/v) in an isocratic mode at a flow rate of 1.4 ml/min. The pH of the mobile phase was adjusted to 7.0 with orthophosphoric acid and UV detection was set at 226 nm.Results: The retention time for bisoprolol fumarate was found to be 2.09 min. The proposed method was validated according to ICH guidelines with respect to linearity, specificity precision, accuracy and robustness. The limit of detection and limit of quantification are calculated and found to be 0.4825 and 1.4621 μg/ml; respectively.Conclusion: The proposed method can help research studies, quality control and routine analysis with lesser resources available. The results of the assay of pharmaceutical formulation of the developed method are highly reliable and reproducible and is in good agreement with the label claim of the medicines.Keywords: Bisoprolol, High-Performance Liquid Chromatography, Validation, ICH guidelines

scholarly journals Development and Validation of UV Spectrophotometric Method For Determination of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Forms

2017 ◽  
Vol 6 (5) ◽  
pp. 196-199 ◽  
Author(s):  
Shahinaz Mohammed ◽  
Mohammed Adam ◽  
Shaza Shantier
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Recovery Percentage ◽  
Development And Validation ◽  
Tablet Dosage

In this study a simple, accurate and precise UV- spectrophotometric method was developed for the estimation of bisoprolol fumarate (BF) in bulk and tablet dosage form. The method was based on measurement of absorbance of BF aqueous solution at 271nm. Validation was conducted in accordance to ICH guidelines. The calibration curve was linear in the concentration range 5-25 µg/mL with correlation coefficient not less than 0.9986. The limit of detection and limit of quantification were 0.22 μg/ml and 0.66 μg/ml, respectively. Intraday and intermediate precision of the developed method were reflected by the low RSD% values (1.19 and 0.854, respectively). The recovery percentage was 105.0 ± 1.3%, n=3. The proposed method was applied for the assay of BF in three different brands

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF ROTIGOTINE IN NANOSTRUCTURED LIPID CARRIERS

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (08) ◽  
pp. 61-67
Author(s):  
Jagruti B. Prajapati ◽  
Gayatri Patel ◽  
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Nanostructured Lipid Carriers ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Recovery Study ◽  
Nanostructure Lipid Carriers ◽  
Development And Validation

Rotigotine (RTG) loaded Nanostructure Lipid Carriers (NLCs) were developed for the treatment of Parkinson’s disease. To estimate RTG entrapped in NLCs, UV spectrophotometric method was developed and validated. The solvent and wavelength of detection were optimized in order to maximize sensitivity of the proposed method. The method was validated for different parameters like linearity, precision, specificity, accuracy, limit of detection (LOD), limit of quantitation (LOQ) and robustness as per ICH guidelines. A wavelength maximum of RTG in methanol: chloroform (6:4V/V) mixture was found at 273 nm. The method was found to be linear in the range of 40 to 200 µg/mL with a correlation coefficient (r2 ) of 0.998. The accuracy of the method was studied by recovery study and % recovery was found in range of 99 to 100.37 %. The LOD and LOQ were found to be 0.09 µg/mL and 6.1 µg/mL, respectively. The method is simple, accurate and requires relatively inexpensive instrument. The method was used successfully for determination of RTG loaded into NLCs.

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF AGOMELATINE IN NANOSTRUCTURED LIPID CARRIERS

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (03) ◽  
pp. 52-57
Author(s):  
S. D Verma ◽  
J. B. Prajapati ◽  
A. A. Patel ◽  
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Nanostructured Lipid Carriers ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Recovery Study ◽  
Development And Validation

The objective of work was to develop and validate a UV spectrophotometric method for determination of agomelatine (AGM) loaded in nanostructured lipid carriers (NLCs). The solvent and wavelength of detection were optimized in order to maximize sensitivity of proposed method. The method was validated for different parameters like linearity, precision, specificity, accuracy, limit of detection (LOD), limit of quantitation (LOQ) and robustness as per ICH guidelines. A wavelength maximum of AGM in methanol: chloroform (7:3V/V) mixture was found at 235nm. The method was found to be linear in the range of 1 to 6μg/mL with a correlation coefficient (r2) of 0.997. The accuracy of the method was studied by recovery study and % recovery was found in range of 99 to 100.11%. The LOD and LOQ were found to be 0.043μg/mL and 0.141μg/mL respectively. The method is simple, accurate and requires relatively inexpensive instrument. The method was used successfully for determination of AGM loaded into NLCs.

scholarly journals Development and Validation of Spectrophotometric Methods for the Determination of Rasagiline in Pharmaceutical Preparations

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Serife Evrim Kepekci Tekkeli ◽  
Armağan Önal ◽  
Fatemeh Bahadori
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Preparations ◽  
Correlation Coefficients ◽  
Dosage Forms ◽  
Chloranilic Acid ◽  
Spectrophotometric Methods ◽  
H Nmr ◽  
Limit Of Quantitation ◽  
Development And Validation

This study presents three simple, rapid, and accurate spectrophotometric methods for the determination of Rasagiline (RSG) in pharmaceutical preparations. The determination procedures depend on the reaction of RSG with chloranilic acid for method A, tetrachloro-1,4-benzoquinone for method B, and 7,7,8,8-tetracyanoquinodimethane for method C. The colored products were quantitated spectrophotometrically at 524, 535, and 843 nm for methods A, B, and C, respectively. Different variables affecting the reaction were optimized. Linearity ranges of the methods with good correlation coefficients (0.9988–0.9996) were observed as 25–300 µg mL−1, 25–350 µg mL−1, and 50–500 µg mL−1for methods A, B, and C, respectively. The formation of products takes place through different mechanisms. The sites of interaction were confirmed by elemental analysis using IR and1H-NMR spectroscopy. The validation of the methods was carried out in terms of specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation. No interference was observed from concomitants usually present in dosage forms. The methods were applied successfully to the determination of RSG in pharmaceutical preparations.

scholarly journals Development and Validation of a HPLC Method for Determination of Anastrozole in Tablet Dosage Form

2011 ◽  
Vol 8 (2) ◽  
pp. 794-797 ◽  
Author(s):  
D. Sathis Kumar ◽  
A. Harani ◽  
D. Sridhar ◽  
David Banji ◽  
Knv Rao ◽  
...  
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Solid Dosage ◽  
Quantitation Limit ◽  
Limit Of Quantitation ◽  
Isocratic Hplc ◽  
Development And Validation ◽  
Tablet Dosage

A simple, economic, accurate reverse phase isocratic HPLC method was developed for the quantitation of anastrozole in tablet dosage form. The quantification was carried out using Gracesmart RP18, 5 μ (100 mmx4.6 mm) with UV detected at 215 nm. The elution was achieved isocratically with a mobile phase comprising a mixture of buffer (pH 6.0) and acetonitrile (1:1, v/v). The flow rate was 1.0 mL/min The procedure was validated as per ICH rules for Accuracy, Precision, Detection limit, Linearity, Reproducibility and Quantitation limit. The linearity concentration range was 10-20 mcg/mL with the correlation coefficient of 0.9935. The percentage recovery for Anastrozole was found to be 97.31±2.2%. Limit of detection and limit of quantitation values were found to be 0.351 mcg/mL and 1.053 mcg/mL. The method has been successfully used to analyze commercial solid dosage containing 1mg of anastrozole with good recoveries and proved to be robust.

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