scholarly journals DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF GEMCITABINE HYDROCHLORIDE IN BULK AND POLYMERIC NANOPARTICLES

2017 ◽  
Vol 9 (5) ◽  
pp. 60 ◽  
Author(s):  
Taranjit Kaur ◽  
Sukhjinder Kaur ◽  
Parminderjit Kaur
Keyword(s):  
Polymeric Nanoparticles ◽  
Visible Spectroscopy ◽  
International Conference ◽  
Spectrophotometric Methods ◽  
Gemcitabine Hydrochloride ◽  
Double Beam ◽  
Uv Visible ◽  
Formulation Analysis ◽  
Development And Validation

Objective: The objective of the present work was to develop and validate a novel, specific, precise and reliable method for estimation of gemcitabine hydrochloride in bulk and polymeric nanoparticles using UV-visible spectroscopy method.Methods: The UV-Visible spectrophotometric determination was performed with double beam Systronics UV-visible spectrophotometer; model UV-2201 (India). The proposed methods were validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, and formulation analysis as per international conference on harmonization (ICH) guidelines.Results: The method was based on measurement of absorbance at wavelength maxima i.e. 267.2 nm, λmax of the drug in distilled water, phosphate buffer pH 6.8 and 7.4. The method obeyed Beer Lambert’s law in the concentration range of 5-30 µg/ml andR2-value was found to be 0.999. Moreover, the % drug recovered from polymeric nanoparticles was found to be 97.97%.Conclusion: According to results, the currently developed method shows compliance with acceptance criteria with Q2 (R1) and international conference on harmonization (2005) guidelines, because the % RSD was found to be less than 2%. The developed method was simple, accurate and précised.

scholarly journals PRELIMINARY VALIDATION OF UV SPECTROPHOTOMETRIC FOR DETERMINATION OF ANTIEMETIC DRUG APREPITANT IN BULK FORM

2020 ◽  
Vol 11 (11) ◽  
pp. 49-53
Author(s):  
Anuradha Kumari ◽  
Parminderjit Kaur
Keyword(s):  
Tween 80 ◽  
Antiemetic Drug ◽  
Acceptance Criteria ◽  
International Conference ◽  
Ich Guidelines ◽  
Preliminary Validation ◽  
Double Beam ◽  
Uv Visible ◽  
Formulation Analysis

Objective: The main objective of this work was to put forth the assorted strategies to develop and validate a novel, specific, precise and reliable method for estimation of aprepitant in bulk using UV-visible spectroscopy method. Method: The validation of Aprepitant was done by using UV-visible spectrophotometric method by using double beam systronics UV-visible spectrometer, model UV-2201 (India). The validation method involves various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits of formulation analysis according to International Conference on Harmonization (ICH) guidelines. Results: UV-spectroscopic determination was carried out at maximum absorption 263.6nm using pH 6.8 buffer & 1.1% tween 80 and 263.8nm using methanol and distilled water. The method obeyed Beer Lambert’s Law in the concentration range of 8-48µg/ml and R2 was found to be 0.999. Conclusion: As per the results were concerned, the %RSD was found to be less than 2% which is compliance with the acceptance criteria of Q1 (R1) and According to results, the currently developed method shows compliance with acceptance criteria with Q1 (R1) and international conference on harmonization (2005) guidelines. Thus, the developed method was found to be simple accurate and précised.

scholarly journals DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF HYDROQUINONE IN BULK, MARKETED CREAM AND PREAPARED NLC FORMULATION

2017 ◽  
Vol 9 (5) ◽  
pp. 102
Author(s):  
Sukhjinder Kaur ◽  
Taranjit Kaur ◽  
Gurdeep Kaur ◽  
Shivani Verma
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Pure Form ◽  
Nanostructured Lipid Carrier ◽  
Limit Of Quantification ◽  
Double Beam ◽  
Uv Visible ◽  
Development And Validation

Objective: The aim of the present work was to develop a simple, rapid, accurate and economical UV-visible spectrophotometric method for the determination of hydroquinone (HQ) in its pure form, marketed formulation as well as in the prepared nanostructured lipid carrier (NLC) systems and to validate the developed method.Methods: HQ was estimated at UV maxima of 289.6 nm in pH 5.5 phosphate buffer using UV-Visible double beam spectrophotometer. Following the guidelines of the International Conference on Harmonization (ICH), the method was validated for various analytical parameters like linearity, precision, and accuracy robustness, ruggedness, limit of detection, quantification limit, and formulation analysis.Results: The obtained results of the analysis were validated statistically. Recovery studies were performed to confirm the accuracy of the proposed method. In the developed method, linearity over the concentration range of 5-40 μg/ml of HQ was observed with the correlation coefficient of 0.998 and found in good agreement with Beer Lambert’s law. The precision (intra-day and inter-day) of the method was found within official RCD limits (RSD<2%).Conclusion: The sensitivity of the method was assessed by determining the limit of detection and limit of quantification. It could be concluded from the results obtained that the purposed method for estimation of HQ in pure form, in the marketed ointment and in the prepared NLC-formulation was simple, rapid, accurate, precise and economical. It can be used successfully in the quality control of pharmaceutical formulations and for the routine laboratory analysis.

Development and Validation of UV-Spectrophotometric Methods for the Determination of Berberine in Polymeric Nanoparticles

2019 ◽  
Vol 11 (12) ◽  
pp. 1273-1278
Author(s):  
Md Ali Mujtaba
Keyword(s):  
Phosphate Buffer ◽  
Limit Of Detection ◽  
Polymeric Nanoparticles ◽  
Uv Spectroscopy ◽  
Pharmaceutical Formulation ◽  
Limit Of Quantification ◽  
Spectrophotometric Methods ◽  
Relative Standard ◽  
Development And Validation

A simple, specific, economic, accurate, and reproducible UV-spectrophotometric methods were developed and validated for the estimation of berberine (BRC) in bulk and pharmaceutical formulation. The λmax of BRC in 0.1 N hydrochloric acid (pH 1.2), phosphate buffer (pH 6.8), and water was found to be 346 nm, 343 nm and 260 nm respectively. Beer's law was obeyed in the concentration range of 5–30 μg/ml (R2 = 0.9698) in water, 5–25 μg/ml (R2 = 0.9991) in 0.1 N HCl buffer (pH 1.2) and 5–35 μg/ml (R2 = 0.9935) in phosphate buffer (pH 6.8). These methods were tested, and validated for various parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD), and limit of quantification (LOQ) according to ICH guidelines. The method showed good reproducibility and recovery with percent relative standard deviation less than 2%. Moreover, the accuracy and precision obtained implied that UV spectroscopy can be a cheap, reliable, and less time consuming alternative for chromatographic analysis. The proposed methods were successfully applied for the determination of BRC in pharmaceutical formulation. The BRC estimated from the formulation was found to be well within limits (±5% of the labelled content of the formulations). The proposed methods are highly sensitive, precise, accurate, and can be employed for the routine analysis of berberine in bulks as well as in the commercial formulations.

scholarly journals Oxcarbazepine: validation and application of an analytical method

2010 ◽  
Vol 46 (2) ◽  
pp. 265-272 ◽  
Author(s):  
Paula Cristina Rezende Enéas ◽  
Renata Barbosa de Oliveira ◽  
Gerson Antônio Pianetti
Keyword(s):  
Spectrophotometric Method ◽  
Analytical Method ◽  
Disintegration Time ◽  
International Conference ◽  
Pharmacopoeial Monograph ◽  
Development And Validation ◽  
Excipient Compatibility

Oxcarbazepine (OXC) is an important anticonvulsant and mood stabilizing drug. A pharmacopoeial monograph for OXC is not yet available and therefore the development and validation of a new analytical method for quantification of this drug is essential. In the present study, a UV spectrophotometric method for the determination of OXC was developed. The various parameters, such as linearity, precision, accuracy and specificity, were studied according to International Conference on Harmonization Guidelines. Batches of 150 mg OXC capsules were prepared and analyzed using the validated UV method. The formulations were also evaluated for parameters including drug-excipient compatibility, flowability, uniformity of weight, disintegration time, assay, uniformity of content and the amount of drug dissolved during the first hour.

scholarly journals DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DULOXETINE

2019 ◽  
pp. 27-31
Author(s):  
LIPSA SAMAL ◽  
AMARESH PRUSTY
Keyword(s):  
Spectrophotometric Method ◽  
Spectroscopic Method ◽  
Solvent System ◽  
Spectrophotometric Analysis ◽  
Thiophene Derivative ◽  
Experimental Conditions ◽  
Relative Standard ◽  
Uv Visible ◽  
Development And Validation

Objective: The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of duloxetine, which is a thiophene derivative and a selective neurotransmitter reuptake inhibitor for serotonin, norepinephrine, and to lesser degree dopamine. Methods: The UV Spectrophotometric analysis was performed using Shimadzu UV-1800 and Shimadzu UV-1700 spectrophotometer by using solvent system acetonitrile and water in the ratio of 8:2. Detection was performed at a wavelength of 290 nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters linearity, accuracy, precision, ruggedness, and robustness, LOD and LOQ. Results: The UV Spectrophotometric method was found linear in the range of 10-50 μg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries were found to be higher than 99% in all experimental conditions. Conclusion: Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and suitable for the determination of Duloxetine for routine analysis.

The use of UV-visible spectroscopy for the determination of hydrophobic interactions between neuropeptides and membrane model systems

Biopolymers ◽  
1992 ◽  
Vol 32 (8) ◽  
pp. 1061-1064 ◽  
Author(s):  
John K. Young ◽  
William H. Graham ◽  
Debbie J. Beard ◽  
Rickey P. Hicks
Keyword(s):  
Hydrophobic Interactions ◽  
Model Systems ◽  
Membrane Model ◽  
Visible Spectroscopy ◽  
Uv Visible
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