scholarly journals Development and validation of a UV-Visible method for the determination of the active principle Efavirenz in tablets

2020 ◽  
Vol 14 (1) ◽  
pp. 279-288
Author(s):  
Nassifatou Koko Tittikpina ◽  
Thierno Mouhamed Wane ◽  
Diery Diouf ◽  
Khadidiatou Thiam ◽  
Amadou Diop ◽  
...  
Keyword(s):  
Active Principle ◽  
Tolerance Limits ◽  
African Countries ◽  
Accuracy Profile ◽  
Antiretroviral Drug ◽  
Upper Limits ◽  
Uv Visible ◽  
Development And Validation ◽  
Lower Limits

Methods proposed by pharmacopeias to control the quality of Efavirenz, an antiretroviral drug used in the treatment of AIDS are based on expensive equipment which are most of the time not available in African countries. To solve this issue, using UV-visible spectrophotometry, a cheap and easy-to-use device available in many laboratories on the African continent; a sensitive, reliable, simple and rapid method has been validated for the determination of the active substance Evafirenz in Efavirenz tablets, to control their quality by checking its dosage. The accuracy profile approach was adopted. The response function gave a correlation coefficient R2 = 0.9987. The detection and quantification limits were 0.15625 μg / mL and 0.515625 μg / mL, respectively. The acceptability limit has been set at 15%. The tolerance limits for the different concentration levels (80, 100 and 120%) are represented respectively as follows: lower limits 86.2; 90.3 and 96.1%; upper limits 100.2; 106.3 and 113.7%. The tolerance limits are within the acceptability limits for values around 100% concentration (7 μg / mL). Therefore, the method was declared valid and reliable for the analysis of Efavirenz in Efavirenz tablets and could routinely be used in laboratories for the quality control of EFAVIRENZ drug. © 2020 International Formulae Group. All rights reserved. Keywords: Efavirenz, accuracy profile, spectrophotometry, pharmaceutical formulation

scholarly journals Validation of an UV-Visible spectrophotometry assay method for the determination of chlorpheniramine maleate tablets without prior extraction

2021 ◽  
Vol 15 (1) ◽  
pp. 273-281
Author(s):  
Linda Carole Djiambeu Chawe ◽  
Nassifatou Koko Tittikpina ◽  
Serigne Momar Ndiaye ◽  
Amadou Diop ◽  
Bara Ndiaye ◽  
...  
Keyword(s):  
Raw Material ◽  
Assay Method ◽  
Tolerance Limits ◽  
Chlorpheniramine Maleate ◽  
Visible Spectrophotometry ◽  
Accuracy Profile ◽  
Upper Limits ◽  
Uv Visible ◽  
Lower Limits

Methods proposed by pharmacopeias to check the quality of chlorpheniramine maleate tablets are multi steps methods which involve extraction and present issues with repeatability. An alternative method is proposed with a sensitive, reliable, simple and rapid UV-VISIBLE spectrophotometry method developed for the determination without extraction of chlorpheniramine maleate in tablets. The method was validated using the accuracy profile approach with an accuracy ranging from 99.70 to 100.46%. Analysis was done using 0.25 mol/L sulfuric acid, distilled water, and raw material in a room at 23 °C for 25 to 30 minutes. Chlorpheniramine maleate concentration varied from 0.018 to 0.03 mg/mL. The method was found to be specific with the appearance of the corresponding maxima at 265 nm and a correlation coefficient (R2 ) of 0.9993. Limits of detection and quantification were respectively 1.39 × 10-4and 2.26 × 10-3 mg/mL. The tolerance limits for the different concentration levels (75, 100 and 125%) were respectively: 88.37; 92.74 and91.62% for lower limits and 111.03; 108.17 and 108.02% for upper limits. It was observed that the tolerance limits were within the limits of acceptability set at 20%. Consequently, the method was declared valid and reliable for routine analysis of chlorpheniramine maleate in tablets containing chlorphenamine as active principle.Keywords : Chlorpheniramine maleate, tablets, accuracy profile, assay method without extraction, validation

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.

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.

scholarly journals Development and Validation of Novel Analytical Simultaneous Estimation Based UV Spectrophotometric Method for Doxycycline and Levofloxacin Determination

2021 ◽  
Vol 12 (4) ◽  
pp. 5458-5478
Keyword(s):  
Solvent System ◽  
Quality Analysis ◽  
Simultaneous Estimation ◽  
Literature Study ◽  
Drug Products ◽  
Ich Guidelines ◽  
Percent Recovery ◽  
Uv Visible ◽  
Development And Validation

The thorough literature study uncovered that none of the most perceived pharmacopeias or any journals includes a method for simultaneous estimation of Doxycycline and Levofloxacin in combination by UV/Visible spectroscopy. So, it was felt fundamental to build up a system that will serve as a solid, precise UV technique for the simultaneous estimation of Doxycycline and Levofloxacin. DOXH and LVXH showed λmax at 273nm and 287nm respectively, and iso-absorptive point at 280nm in Phosphate buffer pH 6.8 prepared in Water: Methanol (80:20) dissolvable solvent system. Beer Lambert's law obeyed by both drugs within the concentration range of 2-20 μg/ml & r2 values of 0.9999 and 0.9998, which shows the good linearity. The method has been validated statistically and quantitatively regarding linearity, precision, LOD, LOQ, accuracy, and specificity according to the ICH guidelines. LOD for DOXH and LVXH were found to be 1.41 and 0.63 μg/ml, the LOQ was 4.30 and 1.92 μg/ml, respectively. Percent recovery at recovery level of 80%, 100% & 120% for DOXH was found to be 99.7, 99.66 & 99.69 & for LVXH 99.58, 99.66 & 99.63 respectively. Intra-day, Inter-day & precision analysis by different analyst was found to be 0.767, 0.563, 0.440 %RSD for DOXH & 0.507, 0.532, 0.708 % RSD for LVXH. Sandell's sensitivity was discovered to be adequate, and this shows that extremely less measure of the two medications can be successfully recognized by this technique. Finally, it was concluded, the developed & validated method was helpful and appropriate for regular quality analysis and simultaneous determination of drug products containing DOXH and LVXH in combination.

Melphan As Anticancer And New Insights Of Drug As Parenteral Dosage Form Against SARS-CoV-2 By Using Development And Validation

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 1437-1446
Author(s):  
Vijayalakshmi Kancharla ◽  
Kumar Abbaraju V D N ◽  
Andrews B S A ◽  
Nagaraju Dasari ◽  
Nagu Korupolu
Keyword(s):  
Hplc Method ◽  
High Dose ◽  
Isopropyl Ester ◽  
Stressed Condition ◽  
Chromatography Analysis ◽  
Induction Regimen ◽  
Uv Visible ◽  
Development And Validation ◽  
Better Than

A validated HPLC method was developed for the determination of Melphan (MPA) in pharmaceutical formulation. LC 20AT pump and UV-Visible detector with flexible wavelength programme and Rheodyne injector are used in this present problem. Phenomenex Synergi C18, 250 mm × 4.6 mm, 4µm or equivalent is used for this chromatography analysis. Column used in this measurement is Phenomenex Synergi C18,250mm×4.6mm,4µm or equivalent. Specificity (stressed condition) is confirmed by no co-elution of diluent peaks, Blank as diluent, excipients peaks, Monohydroxy MPA, Dihydroxy MPA, Isopropyl ester and dimer impurity were not interfere with MPA Peak along with each other. Obtained results are 1.2 and 270103 respectively. The method developed is simple and is better than the methods reported in the literature. With the help of different studies, therefore, we recommend pursuing an induction regimen of up to six cycles in all patients to postpone treatment with high-dose MPA. By using various studies, we recommend pursuing an induction regimen of up to six cycles in all patients to postpone treatment with high-dose MPA for SARS-CoV-2.

Bioanalytical method development and validation of UV spectrophotometric method for estimation of Bumetanide spiked in human urine

2021 ◽  
Vol 11 (2) ◽  
pp. 241-248
Author(s):  
Bhavya sri Khagga ◽  
Kavya.Parelli
Keyword(s):  
Spectrophotometric Method ◽  
Human Urine ◽  
Method Development ◽  
Uv Detector ◽  
Bioanalytical Method ◽  
Method Development And Validation ◽  
Uv Visible ◽  
Development And Validation ◽  
Spiked Human Urine

The main purpose of this study was to develop a simple precise, rapid and accurate UV-visible spectrophotometric method for determination of Bumetanide in spiked human urine by extracting the Bumetanide from spiked human urine using ethyl acetate after extraction it was scanned between 200-400nm by using UV detector and its absorbance maxima was found to be 222nm.The calibration curve was linear in the range of 1-17 µg/ml. .the recovery and assay studies of bumetanide were within 93-94.85% indicating that the proposed method can be estimation of bumetanide.

Analytical Method Development and Validation of Prucalopride Succinate in Bulk and Formulation by UV-Visible Spectrophotometry

2021 ◽  
pp. 4189-4191
Author(s):  
A.C. Bhosale ◽  
V.C. Bhagat ◽  
V. V Kunjir ◽  
D.P. Kardile ◽  
R.V. Shete
Keyword(s):  
Quantitative Determination ◽  
Spectrophotometric Method ◽  
Analytical Method ◽  
Method Development ◽  
Routine Analysis ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Uv Visible ◽  
Development And Validation

Purpose: Analytical method development and validation for the quantitative determination of Prucalopride succinate in bulk and tablet formulation which plays major role in the development and manufacture of pharmaceuticals. Methods: In the present work a simple, rapid and reproducible UV-Visible Spectrophotometric method was developed and validated according to ICH guidelines. Results and Conclusions: The parameters linearity, specificity, precision, accuracy, and robustness were studied. The wavelength 243nm was selected for the estimation of drug using methanol as a solvent. The drug obeys Beer-lambert’s law over the concentration range 2-10μg/ml. The accuracy of the method was assessed by recovery studies and was found between 97.2- 98.3 %. The method was successfully applied for routine analysis of Prucalopride succinate in bulk and formulation.

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 Development and Validation of UV-Visible Spectrophotometric Method for the Determination of 5-Hydroxymethyl Furfural Content in Canned Malt Drinks and Fruit Juices in Ghana

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Joseph K. Adu ◽  
Cedric D. K. Amengor ◽  
Emmanuel Orman ◽  
Nurudeen Mohammed Ibrahim ◽  
Maryjane O. Ifunanya ◽  
...  
Keyword(s):  
Ultraviolet Radiation ◽  
Spectrophotometric Method ◽  
Manufacturing Process ◽  
Fruit Juice ◽  
Solvent System ◽  
Maximum Absorption ◽  
Hydroxymethyl Furfural ◽  
Uv Visible ◽  
Development And Validation

A simple, rapid, accurate, and less expensive spectrophotometric method has been developed for the quantitation of 5-hydroxymethyl furfural (5-HMF) levels in canned malt drinks and fruit juice drinks sampled in the Kumasi Metropolis, Ghana. The quantitation is based on the selective maximum absorption of ultraviolet radiation by 5-HMF at the wavelength (λmax) of 284 nm using acetonitrile : water (50 : 50 v/v) as the solvent system. The method was established to be specific, precise, and accurate over a concentration range of 0.001 mg/ml–0.02 mg/ml. 5-HMF levels in fruit juice samples (A1–A10) were between 0.132 mg/ml and 0.438 mg/ml, and these levels were shown to be comparable (t = 2.200;p=0.0553) to the contents in the canned malt samples (M1–M10) which were between 0.3140 mg/ml and 0.7170 mg/ml. The study failed to show any dependence of 5-HMF levels on the composition of the product as well as the manufacturing process adopted. The length of storage did also not significantly affect the 5-HMF levels in the products.

scholarly journals Development and Validation of RP-HPLC Method for Estimation of Amlodipine Besylate and Celecoxib in Pharmaceutical Formulation

2020 ◽  
Vol 10 (6) ◽  
pp. 31-36
Author(s):  
P Nagamani ◽  
SY Manjunath ◽  
T Hemant Kumar
Keyword(s):  
High Performance ◽  
Pharmaceutical Products ◽  
Hplc Method ◽  
Amlodipine Besylate ◽  
Linear Calibration ◽  
Rp Hplc ◽  
Uv Visible ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise, accurate, and rapid reverse phase-high performance liquid chromatography (RP-HPLC) method with UV-Visible detector has been developed and subsequently validated for the simultaneous determination of amlodipine besylate(AML) and celecoxib(CEL) in their combined tablet dosage form. The separation was based on the use of a Flowrosil C18   analytical column (250 × 4.6 mm, i.d., 5 µm). The mobile phase consisted of a mixture of 80 volumes of acetonitrile and 20 volumes of water. The chromatography was performed by isocratic elution at a flow rate of 1 mL/min. Analytes were detected at 250 nm, with linear calibration curves at concentration ranges of 2-12 µg/ml and 50-300 µg/ml for AML and CEL respectively. The retention time of AML and CEL were 1.98 and 3.15 min respectively. The recoveries obtained were 99.46‒101.36% for AML, 99.57‒101.42% and 99.96–100.87 % for CEL. The method was validated according to International conference of harmonisation guidelines in terms of accuracy, precision, specificity, robustness, limits of detection and quantitation, and other aspects of analytical validation. The developed method was applied successfully for HPLC analysis of commercial pharmaceutical products including AML and CEL. Keywords: Amlodipine besylate; Celecoxib; RP-HPLC.

Sign in / Sign up

Export Citation Format

Share Document