scholarly journals Development and validation of UV spectrophotometric method for quantitative estimation of Promethazine HCl in phosphate buffer saline pH 7.4

2013 ◽  
Vol 2 (8) ◽  
pp. 141-142
Author(s):  
Dwi Nurahmanto
Keyword(s):  
Phosphate Buffer ◽  
Quantitative Estimation ◽  
Pharmaceutical Journal ◽  
Analytical Validation ◽  
Phosphate Buffer Saline ◽  
Validation Procedure ◽  
Development And Validation ◽  
Light Absorbance

A new, sensitive, rapid, simple, specific and economical procedure has been developed for determination Promethazine HCl in phosphate buffer saline pH 7.4. The purpose of this analytical validation procedure is to determine a process of assessment and to validate it by laboratory experiments to prove that the method meets the minimum standard for laboratory use. This analytical method for the determination of Promethazine HCl in phosphate buffer saline pH 7.4 can be used to estimate the amount of promethazine HCl penetrated and dissolved in the blood vessels in vitro by penetration study. The method is based on the ultraviolet light absorbance at 251 nm which is the maximum wavelength of the concerned drug. This method can be succesfully applied for determination of drug in phosphate buffer saline pH 7.4 . The results of the analysis have been validated statistically and by recovery studies.DOI: http://dx.doi.org/10.3329/icpj.v2i8.15589 International Current Pharmaceutical Journal, July 2013, 2(8): 141-142

scholarly journals Development of new spectrophotometric method for estimation of tenofovir disoproxil fumarate using MBTH reagent

2015 ◽  
Vol 4 (4) ◽  
pp. 378-381 ◽  
Author(s):  
Mannem Sri Varsha ◽  
N. Raghavendra Babu ◽  
Yenumula Padmavathi ◽  
P. Ravi Kumar
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Visible Region ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Journal ◽  
Specific Procedure ◽  
Analytical Validation ◽  
Pharmaceutical Dosage Forms ◽  
Secondary Amine Group ◽  
Validation Procedure

A new simple, sensitive and specific procedure has been developed for determination of tenofovir disoproxil fumarate in bulk and pharmaceutical dosage forms using MBTH reagent. The purpose of this analytical validation procedure is to validate it by laboratory experiments to prove that the method meets the minimum standards for laboratory use. 3-methyl-2-bezothiazoline hydrazone reacts with the secondary amine group of tenofovir in the presence of oxidizing agent, ferric chloride. The resulting apple green coloured chromogen when measured spectrophotometrically in visible region (i.e., 400-800nm) shows a maximum absorbance at 626.5nm. This method can be successfully applied for the determination of drug content in pharmaceutical formulations. The results of analysis have been validated statistically.DOI: http://dx.doi.org/10.3329/icpj.v4i4.22620 International Current Pharmaceutical Journal, March 2015, 4(4): 378-381 

scholarly journals Development and validation of UV spectrophotometric method for quantitative estimation of nitroglycerin in pharmaceutical dosage form

1970 ◽  
Vol 1 (1) ◽  
pp. 1-5 ◽  
Author(s):  
Rajia Sultana Nijhu ◽  
Dewan Taslima Akhter ◽  
Yeakuty Marzan Jhanker
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Analytical Procedure ◽  
Quantitative Estimation ◽  
Pharmaceutical Journal ◽  
Spectroscopy Analysis ◽  
Pharmaceutical Dosage Form ◽  
Tablet Form ◽  
Development And Validation

A new, simple, specific, sensitive, rapid and economical procedure has been developed for determination of Nitroglycerin in its dosage form. The objective of this validation of an analytical procedure is to demonstrate that the drug Nitroglycerin is suitable for its intended purpose. The analytical method development recommends the quality, purity and specificity of the drug Nitroglycerin tablet form during the manufacturing process and hence the standard of the drug may not vary, which produce the desirable therapeutic effect. The method is based on the ultraviolet absorbance maxima of the above drug at 210nm. The drug obeyed Beer's law in the concentration range of 15μg/ml in methanol. The proposed methods were successfully applied for the determination of drug in commercial tablet preparations. The results of the analysis have been validated statistically and by recovery studies. Key Words: Nitroglycerin; ultraviolet spectroscopy; analysis; dosage form; validation.DOI: http://dx.doi.org/10.3329/icpj.v1i1.9217 International Current Pharmaceutical Journal 2011, 1(1): 1-5

scholarly journals Determination of eight carbonyl compounds in aerosols trapped in phosphate buffer saline solutions to support in vitro assessment studies

Talanta ◽  
2018 ◽  
Vol 184 ◽  
pp. 42-49 ◽  
Author(s):  
Roberto Buratto ◽  
Daniela Correia ◽  
Monique Parel ◽  
Maude Crenna ◽  
Mickaël Bilger ◽  
...  
Keyword(s):  
Phosphate Buffer ◽  
Carbonyl Compounds ◽  
Phosphate Buffer Saline ◽  
In Vitro Assessment ◽  
Saline Solutions

scholarly journals Development and validation of UV-spectrophotometric methods for quantitative estimation of Prothionamide in pure and pharmaceutical dosage forms

2015 ◽  
Vol 4 (7) ◽  
pp. 402-404 ◽  
Author(s):  
Sujit Kumar Debnath ◽  
S. Saisivam ◽  
Dillip Kumar Dash ◽  
Monalisha Debnath
Keyword(s):  
Quantitative Estimation ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Journal ◽  
Routine Practice ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Validation Parameters ◽  
Bulk Drug ◽  
Development And Validation

UV Spectrophotometric method was developed and validated for the quantitative determination of Prothionamide in bulk drug and in pharmaceutical formulations. Prothionamide shows the maximum absorbance at 288 nm in phosphate buffer (pH 7.4). Prothionamide follows Beer’s law in the concentration range of 4-20 µg/ml (r2 = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.406 and 1.229 µg/ml respectively. Accuracy and precision were found to be satisfactory. The developed methods were validated according to ICH guidelines. All the validation parameters were found to be satisfactory accordance with the standard values. Therefore, the proposed method can be used for routine practice for the determination of Prothionamide in assay of bulk drug and pharmaceutical formulations.International Current Pharmaceutical Journal, June 2015, 4(7): 402-404

scholarly journals Development and Validation of an Eco-friendly HPLC-UV-DAD Method for the Determination of Allopurinol in Pharmaceuticals with Application to In vitro Dissolution Studies

2021 ◽  
Vol 11 (5) ◽  
pp. 13089-13101
Keyword(s):  
Factorial Design ◽  
Matrix Effects ◽  
Dissolution Kinetics ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Dissolution Studies ◽  
Dissolution Tests ◽  
Development And Validation

In this study, a sustainable HPLC-UV-DAD method was developed and validated for the determination of allopurinol in tablets and optimization of the dissolution test using factorial design. The separation of the analyte from the sample matrix was achieved in 3.01 minutes in a C8 column (4.6 mm X 150 mm X 5 μm), using mobile phase 0.1 mol L-1 HCl (25%) + ethanol (50%) + ultrapure water (25%) by UV detection at 249 nm. The method presented satisfactory analytical parameters of validation (specificity, selectivity, linearity, stability, precision, accuracy, and robustness), showing no matrix effects. The dissolution test was optimized by complete factorial design 23 and, the optimal conditions were: HCl 0.001 mol L-1, apparatus II (paddle) and 75 rpm. The analytical procedures and dissolution tests were applied to allopurinol tablets marketed in Bahia, Brazil, to evaluate the dissolution studies. The pharmaceuticals had similar dissolution profiles and first-order dissolution kinetics. This new and sustainable HPLC-UV-DAD method is friendly to the environment and can be used for the routine pharmaceutical analysis of allopurinol in fixed dosage forms.

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 spectroscopic methods for simultaneous estimation of ciprofloxacin and tinidazole in tablet formulation

2012 ◽  
Vol 1 (10) ◽  
pp. 317-321 ◽  
Author(s):  
Sowjanya Gummadi ◽  
Devi Thota ◽  
Sri Valli Varri ◽  
Pratyusha Vaddi ◽  
Venkata Lakshmi Narasimha Seshagiri Rao
Keyword(s):  
Phosphate Buffer ◽  
Dosage Form ◽  
Pharmaceutical Journal ◽  
Simultaneous Equations ◽  
Simultaneous Estimation ◽  
Spectroscopic Methods ◽  
Good Reproducibility ◽  
Statistical Validation ◽  
Development And Validation ◽  
Tablet Dosage

Two simple, accurate, precise, reproducible and economical UV spectroscopic methods (A &  B) for simultaneous estimation of Ciprofloxacin and Tinidazole in tablet dosage form have been developed. Method A employs solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 271nm and 318nm which are the ?max values of Ciprofloxacin and Tinidazole respectively in phosphate buffer (pH 6.8). Method B is based on the principle of  Q-Analysis where in the absorbance was measured at 292nm (iso-absorptive point) and 271nm (?max of Ciprofloxacin)in phosphate buffer (pH 6.8). Ciprofloxacin and Tinidazole  shows linearity at all the selected wave-lengths and  obeys Beer’s law in the concentration range of 10-35µg/mL and 10-80µg/mL respectively.  Recovery studies for Ciprofloxacin and Tinidazole were performed and the percentage recovery for both the drugs was obtained in the range of 98.1-99.7% (Method A) and 98.0-100.4% (Method B) confirming the accuracy of the proposed method. Both the methods showed good reproducibility and recovery with %RSD less than 2. Statistical validation of the data shows that the proposed methods can be successfully applied for the routine analysis of drugs in commercial tablets.DOI: http://dx.doi.org/10.3329/icpj.v1i10.11849 International Current Pharmaceutical Journal 2012, 1(10): 317-321 

scholarly journals Development and Validation of HPTLC Method for Estimation of Carbamazepine in Formulations and Its In Vitro Release Study

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Rashmin B. Patel ◽  
Mrunali R. Patel ◽  
Kashyap K. Bhatt ◽  
Bharat G. Patel
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
In Vitro Release ◽  
Analysis Data ◽  
Limit Of Quantitation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Vitro Release

A new, simple, and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of Carbamazepine. Carbamazepine was chromatographed on silica gel 60 F254 TLC plate using ethyl acetate-toluene-methanol (5.0 + 4.0 + 1.0 v/v/v) as mobile phase. Carbamazepine was quantified by densitometric analysis at 285 nm. The method was found to give compact spots for the drug (Rf=0.47 ± 0.01). The linear regression analysis data for the calibration plots showed good linear relationship with r2=.9995 in the concentration range 100–600 ng/spot. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The minimum detectable amount was found to be 16.7 ng/spot, whereas the limit of quantitation was found to be 50.44 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of Carbamazepine. The method was successfully employed for the estimation of equilibrium solubility, quantification of Carbamazepine as a bulk drug, in commercially available preparation, and in-house developed mucoadhesive microemulsion formulations and solution.

scholarly journals Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab

2020 ◽  
Vol 15 (2) ◽  
pp. 77-85
Author(s):  
D. I. Zybin ◽  
A. S. Seregin ◽  
A. D. Askretkov ◽  
N. V. Orlova ◽  
Yu. A. Seregin ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Pharmaceutical Analysis ◽  
Comparative Evaluation ◽  
Specific Activity ◽  
In Vitro Method ◽  
Recombinant Monoclonal Antibody ◽  
Development And Validation ◽  
First Time

Objectives. Developing reliable and accurate analytical methods is necessary for comparative pharmaceutical analysis using physicochemical, biological (in vitro), preclinical, and clinical trials. The main objective of this study was to develop and validate an in vitro method for determining the specific activity of the recombinant monoclonal antibody eculizumab.Methods. The method of indirect enzyme immunoassay was used in the study.Results. A method for determining the specific activity of the humanized recombinant monoclonal antibody eculizumab was described and validated for the first time. A comparative evaluation of the specific activity of Soliris® (Alexion Pharmaceuticals Inc., USA), and its biosimilar PRK-001 (Pharmapark, Russia) was performed using the developed method.Conclusions. The similarity of PRK-001 and the original Soliris® in relation to their specific activity, that is, binding to the human complement system C5 protein, was proved. 

scholarly journals Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION

2019 ◽  
pp. 275-279
Author(s):  
VAIBHAV S KHODKE ◽  
GAME MD
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Quality Criteria ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Good Agreement

Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency. Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm. Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims. Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.

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