scholarly journals Method Development and Validation for Quantitative Analysis of Anti-Histamine Promethazine Hydrochloride by RP-UPLC

2021 ◽  
Vol 37 (1) ◽  
pp. 33-39
Author(s):  
Nilesh Takale ◽  
Neelakandan Kaliyaperumal ◽  
Gopalakrishnan Mannathusamy ◽  
Rajarajan Govindasamy
Keyword(s):  
Quantitative Analysis ◽  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Method Development ◽  
Theoretical Plate ◽  
Asymmetry Factor ◽  
Array Detector ◽  
Uv Detector ◽  
Relative Standard ◽  
Promethazine Hydrochloride

The quantitative analysis method for the quantitative analysis of the anti-histaminic drug Promethazine Hydrochloride (PMZ•HCl) is stated by a straightforward, smooth, reliable and reverse step of the ultra-performing liquid chromatographic method (RP-UPLC). Following ICH quidelinesQ2(R1), the RP-UPLC method has been developed and checked. The uniform solution of 3.4% KH2PO4 solution in water, 7.0 pH with dilute KOH, ACN, andMeOH in ratio of 40:40:20, used as a mobile phase. The flow of 0.6 mL/minusing photo diode array detector / UV detector by with wavelength of 254 nm and runtime 3 min. This gives linearty from 80-120 % with correlation coefficient of 0.99988. Repeatability and intermediate precision shows relative standard deviation (percent RSD) of 0.52, 0.24 and a overall RSD of 0.43. Robustness studies show no indicative changes in SST requirements, like asymmetry factor, theoretical plate & percentage relative standard deviation. These criteria's values are well within their acceptability limit. The degradation of promethazine under different stress conditions has been studied and shows that all known impurities and degradants are well separated from promethazine peak.This RP-UPLC is descriptive and accurate.

scholarly journals Rapid and Selective UV Spectrophotometric Method for the Analysis of Ceftazidime

2009 ◽  
Vol 92 (3) ◽  
pp. 820-823 ◽  
Author(s):  
Andréia de Haro Moreno ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Quantitative Evaluation ◽  
Spectrophotometric Method ◽  
Pharmaceutical Preparations ◽  
Pure Form ◽  
Uv Detector ◽  
Relative Standard ◽  
Beer's Law ◽  
Beer’S Law

Abstract A new UV spectrophotometric method was developed for quantitative evaluation of ceftazidime preparations. The UV detector was set at 255 nm. Beer's law is obeyed in the concentration range of 7.014.0 g/mL. The method was found to be selective, linear, accurate, and precise in the specified ranges. Intra- and interday variability for the method were <2 relative standard deviation. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method. This method was successfully used for quantification of ceftazidime in pure form and in pharmaceutical preparations.

scholarly journals UV Spectrophotometric Method Development and Validation of Fimasartan Drug and Its Tablet Formulation

1970 ◽  
Vol 7 (5) ◽  
pp. 25-29
Author(s):  
Kaushik S Agrawal ◽  
Lokesh R Gandhi ◽  
Nitin S. Bhajipale S Bhajipale3
Keyword(s):  
Standard Deviation ◽  
Quantitative Determination ◽  
Relative Standard Deviation ◽  
Spectrophotometric Method ◽  
Method Development ◽  
Cost Effective ◽  
Tablet Formulation ◽  
Relative Standard ◽  
Bulk Drug

A novel, safe and sensitive method of Spectrophotometric estimation in UV - region has been developed for the assay of Fimasartan in its tablet formulation. The present study was undertaken to develop and validate a simple, accurate, precise, reproducible and cost effective UV spectrophotometric method for the estimation of Fimasartan bulk and pharmaceutical formulation. The method have been developed and validated for the assay of Fimasartan using Methanol as diluent. Absorption maximum (λmax) of the drug was found to be 240nm. The quantitative determination of the drug was carried out at 240nm. The method was shown linear in the mentioned concentrations having correlation coefficient R2 of 0.999. The recovery values for Fimasartan ranged from 98.74% to 99.23%.The Percent Relative Standard Deviation of interday and intraday was 0.85% and 0.75% respectively. All the parameters of the analysis were chosen according to the International Conference on Harmonisation guideline and validated statistically using Relative Standard Deviation and Percent Relative Standard Deviation. Hence, proposed method was precise, accurate and cost effective. This method could be applicable for quantitative determination of the bulk drug as well as dosage formulation.   KEY WORDS: 

scholarly journals Analysis of Chloramphenicol and Its Related Compound 2-Amino-1-(4-nitrophenyl)propane-1,3-diol by Reversed-Phase High-Performance Liquid Chromatography with UV Detection

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Fuad Al-Rimawi ◽  
Maher Kharoaf
Keyword(s):  
Liquid Chromatography ◽  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Related Compound ◽  
Reversed Phase ◽  
Eye Drops ◽  
Good Resolution ◽  
Uv Detector ◽  
Federal Drug Administration ◽  
Relative Standard

A simple and stability-indicating liquid chromatographic method is developed for the analysis of chloramphenicol and its related compound 2-amino-1-(4-nitrophenyl)propane-1,3-diol in two pharmaceutical forms. Liquid chromatography with a UV detector at a wavelength of 278 nm using a reversed phase C18 stationary phase has been employed in this study. Isocratic elution is employed using a mixture of sodium pentanesulfonate solution (0.012 M), acetonitrile, and glacial acetic acid (85 : 15 : 1, v/v). This new method is validated in accordance with USP requirements for new methods for assay determination, which include accuracy, precision, specificity, linearity and range. This method shows enough selectivity, sensitivity, accuracy, precision, and linearity range to satisfy Federal Drug Administration/International Conference on Harmonization regulatory requirements. The current method demonstrates good linearity over the range of 0.04–0.16 mg/mL of chloramphenicol. The accuracy of the method is 100.0% with a relative standard deviation of 0.1%. The precision of this method reflected by relative standard deviation of replicates is 0.1%. The method is sensitive with a detection limit of 0.005% for chloramphenicol. The related substance of chloramphenicol (2-amino-1-(4-nitrophenyl)propane-1,3-diol) can be selectively determined with a good resolution in two pharmaceutical forms: eye ointment and eye drops.

scholarly journals Assay method development and validation for butamben drug substance by using high performance liquid chromatographic technique

2020 ◽  
Vol 11 (1) ◽  
pp. 981-984
Author(s):  
Sachin D. Zade ◽  
Padma S. There ◽  
Sunanda S. Aswale ◽  
Shashikant R. Aswale
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Drug Substance ◽  
Assay Method ◽  
Forced Degradation ◽  
Chromatographic Technique ◽  
Relative Standard

Stability indicating assay methodology was developed with UV detection for the simultaneous quantification of Butamben drug substance by HPLC. The separation between degradation impurities and the peak due to Butamben was achieved by using Universal C 18, (100 x 4.6) mm, 5.0-micron column. Mobile Phase was made up of Water, Methanol and Orthrophosphoric acid by mixing 350:650:1 ml, respectively. Isocratic method was used by using flow rate of 1.0 ml/min, UV at 250 nm and column oven temperature at 50°C. Relative standard deviation for standard preparation under system precision was achieved within acceptance criteria. Relative standard deviation for retention time was achieved 0.11%, which shows reproducibility during replicate injections. After the successful development of this method, chemically forced degradation was performed by external acid, alkali and peroxide treatment. Not any degradation peak was interfering with any impurity. This newly developed innovative method is found suitable for the Assay analysis of Butamben API.

Quantitative Analysis of Phenaglycodol

1968 ◽  
Vol 51 (3) ◽  
pp. 631-633
Author(s):  
Robert P Snell
Keyword(s):  
Quantitative Analysis ◽  
Standard Deviation ◽  
Qualitative Analysis ◽  
Relative Standard Deviation ◽  
Carbon Disulfide ◽  
Quantitative Measurement ◽  
Spectrophotometric Analysis ◽  
Relative Standard ◽  
Tablet Preparation

Abstract A procedure has been developed for the quantitative and qualitative infrared spectrophotometric analysis of phenaglycodol in tablets and capsules. The procedure consists of a liquid-liquid partition of the drug between chloroform and an aqueous alkaline phase. The quantitative measurement is made at about 9.85 μ relative to a carbon disulfide reference, using the baseline technique. Qualitative analysis employs the KBr disk technique. Five collaborators obtained a relative standard deviation of ± 1.88% for a tablet preparation and ± 1.61% for a capsule preparation. It is recommended that the method be adopted as official, first action.

scholarly journals ULTRAVIOLET SPECTROPHOTOMETRIC METHOD DEVELOPMENT FOR ESTIMATION OF NEW ANTIVIRAL REPURPOSING DRUG FAVIPIRAVIR

2021 ◽  
pp. 67-69
Author(s):  
JEEVANA JYOTHI B ◽  
VENKATA KAVYA R
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Spectrophotometric Method ◽  
Method Development ◽  
Quantitation Limit ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Recovery Study ◽  
Development And Validation ◽  
Interday Precision

Objective: A new, economical, precise, linear, sensitive, accurate, ultraviolet (UV) spectrophotometric method for the estimation of new antiviral repurposing drug favipiravir as there is no reported simple UV spectrophotometric method for estimation. The efforts were made for development and validation of favipiravir as per ICH guidelines, because drug has a wide scope for formulations to be developed for treating different viruses. Methods: This method was developed using ethanol and water as a solvent. Favipiravir showed the absorption maxima at 234 nm. A Shimadzu UV–visible spectrophotometer (UV JAPAN 1801) was used to carry out spectral analysis. Results: The developed method was linear for a range of 0–10 μg/ml and displayed a good correlation coefficient of 0.9995. Accuracy of the method was estimated using a recovery study. The amount of drug recovered was found to be in the range of 99.30–99.91%. The % relative standard deviation value of intraday precision was found to be 0.408% and interday precision was found to be in the range of 0.348–0.693%. The % relative standard deviation found to be <2 which are indicative of the precision and reproducibility of the method. Detection limit and quantitation limit were noticed as 0.095 and 0.290, respectively. Conclusion: The developed UV spectrophotometric method was validated statistically for linearity, accuracy, precision, and sensitivity and results proved that the method can be employed for routine analysis of favipiravir.

Chromatographic Quantification of Ivermectin and Pranziquantel in the Tablets Using Stability Indicating RP-HPLC Method

2019 ◽  
Vol 25 (3) ◽  
pp. 254-261
Author(s):  
Naga Venkata Suresh Kumar Devaka ◽  
Vallabhaneni Madhusudhan Rao
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Assay Method ◽  
Array Detector ◽  
Limit Of Quantification ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard

Background: A new stability indicating RP-HPLC based assay method was developed to quantify ivermectin and praziquantel simultaneously and applied effectively to tablets. Methods: The simultaneous assay of ivermectin and praziquantel by RP-HPLC was done using an YMC C18 (250 mm × 4.6 mm, 5 µm) column with a mobile phase mixture of 0.1M disodium hydrogen phosphate (pH 4.5) and acetonitrile (55:45, v/v) using a isocratic flow rate of 1.0 ml/min and measured at 242 nm using photodiode array detector. All parameters were validated following the ICH guiding principles. The method was applied to quantify ivermectin and praziquantel simultaneously in tablets. Results: The retention values of ivermectin and praziquantel were 3.465 min and 4.468 min, respectively. The method’s linearity was found to be 1-3 µg/ml (ivermectin) and 25-75 µg/ml (praziquantel). The limit of detection was 0.010 µg/ml (ivermectin) and 0.046 µg/ml (praziquantel); limit of quantification was 0.033 µg/ml (ivermectin) and 0.155 µg/ml (praziquantel). The percent relative standard deviation of ivermectin and praziquantel was ˂1.0%. The percent assay was 99.51% and 99.20% for ivermectin and praziquantel, respectively. In tablets, the percent recovery of ivermectin and praziquantel was 99.60% and 99.38% with a percent relative standard deviation value of 0.353% and 0.106%, respectively. Stability indicating capability of the method was demonstrated through the stress degradation studies. Conclusion: The developed method was proved to be selective, precise and accurate for the quality control of ivermectin and praziquantel in tablets.

scholarly journals Determination of Acetochlor in Technical and Formulated Products by Capillary Gas Chromatography

2001 ◽  
Vol 84 (2) ◽  
pp. 317-322
Author(s):  
Bobbi B Kahn ◽  
David F Tomkins
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Method Development ◽  
Internal Standard ◽  
Test Sample ◽  
Weight Percent ◽  
Flame Ionization ◽  
Relative Standard ◽  
Data Points

Abstract A peer-verified gas chromatographic (GC) method is presented for the weight percent (wt %) determination of acetochlor herbicide in technical and formulated products. During method development, the method was found to be rugged by the Youden Ruggedness Test. Two laboratories with experience in the wt % determination of acetochlor in various matrixes participated in this study. Each laboratory received 10 blind duplicate test samples of the following 5 matrixes: one acetochlor technical and 4, different, emulsifiable concentrate (EC) formulations—Harness® EC (MON 5841), Harness ® Export/Fist (MON 8435), Surpass® EC (HF), and Surpass ® EC (LF). Each participant was asked to make duplicate weighings of each of the test samples and to inject each test sample solution twice. All test samples were analyzed on the same day, and 8 data points (replicates) per matrix were obtained. The test samples were dissolved in acetone that contained dipentyl phthalate as an internal standard. They were analyzed by GC on a 15 m capillary column by using split injection and a flame ionization detector. Acetochlor (wt %) was determined by comparing the ratios of peak area of acetochlor/peak area of dipentyl phthalate internal standard obtained for the test sample and calibration solutions. Repeatability of the method, expressed as the within-laboratory (between replicates) relative standard deviation (RSDr), was found to be 0.09–0.77% for the 5 matrixes. Reproducibility of the method, expressed as the within-test sample relative standard deviation (RSDR), was found to be 0.18–0.78% for the 5 matrixes.

Electrocatalysis Property of DNA-Hydroxyapatite Modified Electrode on Chloramphenicol

2011 ◽  
Vol 306-307 ◽  
pp. 323-326
Author(s):  
Nuo Zhang ◽  
Yan Fang Zhao ◽  
Yu Xue Dai ◽  
Dan Wu ◽  
Bin Du ◽  
...  
Keyword(s):  
Quantitative Analysis ◽  
Standard Deviation ◽  
Detection Limit ◽  
Relative Standard Deviation ◽  
Modified Electrode ◽  
Linear Correlation ◽  
Eye Drops ◽  
Buffer Solution ◽  
Peak Current ◽  
Relative Standard

An electroanalysis method of determining Chloramphenicol (CAP) based on the eletrocalysis property of DNA-hydroxyapatite modified electrode (dsDNA/HAp/GCE) was setted up. In KH2PO4-Na2HPO4 buffer solution with pH 6.0 cotaining 0.1 mol·L-1KCl, the peak current was proportional to the concentration of CAP in the range of 2.80 × 10-7to 3.60 × 10-6mol·L-1, with a detection limit of 1.35 × 10-7mol·L-1. The linear regress equation wasip(μA) = 5.865 + 0.4784 c(µmol·L-1), and the linear correlation coffcient was 0.9942. The method has been successfully applied to the quantitative analysis of CAP in real Chloramphenicol eye drops samples, which totally meet the demand of microanalysis. The relative standard deviation samples analysis results was 1ess than 3%.

An Automated Procedure for the Determination of Ammonia in Tobacco

1972 ◽  
Vol 6 (4) ◽  
Author(s):  
P.F. Collins ◽  
W.W. Lawrence ◽  
J.F. Williams
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Distillation Method ◽  
Relative Standard ◽  
Tobacco Sample ◽  
Automated Determination

AbstractA procedure for the automated determination of ammonia in tobacco has been developed. Ammonia is extracted from the ground tobacco sample with water and is determined with a Technicon Auto Analyser system which employs separation of the ammonia through volatilization followed by colourimetry using the phenate-hypochlorite reaction. The procedure has been applied to a variety of tobaccos containing from 0.02 to 0.5 % ammonia with an overall relative standard deviation of 2 %. The accuracy of the procedure as judged by recovery tests and by comparison to a manual distillation method is considered adequate

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