scholarly journals Development of Rapid UV Spectrophotometric Method for the Estimation of Efavirenz in Formulations

2010 ◽  
Vol 7 (3) ◽  
pp. 856-860 ◽  
Author(s):  
Y. Anand Kumar ◽  
N. Rama Rao
Keyword(s):  
Statistical Methods ◽  
Spectrophotometric Method ◽  
Solvent System ◽  
Sodium Lauryl Sulphate ◽  
Total Drug ◽  
Drug Content ◽  
Oral Formulations ◽  
Ich Guidelines ◽  
Sample Recovery ◽  
Good Agreement

Simple, sensitive, accurate, precise and rapid ultraviolet (UV) spectrophotometric method was developed for the estimation of efavirenz in pure form, its formulations and stability samples. For the estimation of efavirenz, solvent system employed was 1% w/v sodium lauryl sulphate (SLS) and wavelength of detection (λdet) was 247 nm. The developed method was used to estimate the total drug content in two commercially available oral formulations of efavirenz and recovery studies were also carried out. Sample recovery in both the formulations using the above method was in good agreement with their respective labeled claims, thus suggesting the validity of the method and non-interference of formulation excipients in the estimation. The developed method was found to be stability specific and were validated as per ICH guidelines-2005, USP-2000 and statistical methods.

scholarly journals Development of UV-spectrophotometric method and its validation for estimating contents of Prulifloxacin in Simulated Intestinal Fluid

2020 ◽  
pp. 17-21
Author(s):  
KAUSHAL KUMAR ◽  
Sobhna Singh
Keyword(s):  
Spectrophotometric Method ◽  
Calibration Curve ◽  
Phosphate Buffer ◽  
Spectroscopic Method ◽  
Pharmaceutical Formulation ◽  
Routine Analysis ◽  
Intestinal Fluid ◽  
Simulated Intestinal Fluid ◽  
Ich Guidelines ◽  
Good Agreement

This study was performed with an objective of developing and validating an UV-spectroscopic method for estimating contents of prulifloxacin in simulated intestinal fluid (SIF) i.e. phosphate- buffer media with a pH of 6.8 as per ICH guidelines. The λmax for prulifloxacin in phosphate- buffer media pH 6.8 was found to be 272 nanometer. The calibration curve of drug followed linearity in-between 1-9 μg/ml concentration range and correlation co-efficient value was found equal to 0.9995. We tested this proposed method onto the bulk and marketed pharmaceutical formulation (tablets) also in order to find out contents of drug. Using developed method for estimation of prulifloxacin in SIF, drug was found to be in-between 101.91 and 104.02 % in marketed tablets which shows a good agreement with that of the claimed level. Accuracy of developed method was established through recovery experimentation, performed for three spiked percent concentrations- 75%, 100%, and 125%. The % recovery was found to be in between 97.27 and 101.82%. Low values of % RSD supported accuracy as well as the reproducibility of developed method. Precision of developed method was established by good in-limit intraday and interday experimental variations and through repeatability tests. Values of % RSD less than 2 confirmed about precision of developed method. The ruggedness of the developed method was validated by performing drug estimation by two different performers. This proposed spectroscopic method has proved to be a rapid and successful method for routine analysis of prulifloxacin in simulated intestinal fluid.

scholarly journals DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF CLENBUTEROL HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATION

2020 ◽  
pp. 108-110
Author(s):  
SUSHMITA KANKURE ◽  
MALLINATH KALSHETTI ◽  
RAVIKANT PATIL
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulation ◽  
Clenbuterol Hydrochloride ◽  
Ich Guidelines ◽  
Water As Solvent ◽  
Repeatability And Reproducibility ◽  
Development And Validation ◽  
Dosage Formulation ◽  
Good Agreement

Objective: The objective of the present work is to develop a simple, rapid, economic UV spectrophotometric method for quantification of clenbuterol hydrochloride in bulk and pharmaceutical formulation as per ICH guidelines. Methods: A UV spectrophotometric method has been developed using water as solvent to determine the Clenbuterol hydrochloride in bulk and pharmaceutical dosage formulation. The λmax of Clenbuterol hydrochloride in water was found to be 242 nm. Results: The drug was proved linear in the range of 10-50μg/ml and exhibited good correlation coefficient (R2 = 0.9987) and excellent mean recovery (98-100%). The %RSD for intra-day and inter-day precision was found to be 0.053997676 and 0.359081556 respectively. The LOD and LOQ of clenbuterol hydrochloride was found to be 3.704448 and 11.2256 respectively. This method was successfully applied to clenbuterol content in marketed brands and the results were in good agreement with the label claims. Conclusion: The method was validated for linearity, precision, repeatability and reproducibility. The obtained results proved that the method can be employed for the routine analysis of clenbuterol in bulks as well as in commercial formulations.

scholarly journals Development and Validation of Simple UV Spectrophotometric Method for the Estimation of Dextromethorphan Hydrobromide in Bulk and Marketed Dosage Formulations

2016 ◽  
Vol 8 (03) ◽  
Author(s):  
Vineeta V. Khanvilkar ◽  
Rupali Kothekar
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Solid Dosage ◽  
Ich Guidelines ◽  
Chewable Tablets ◽  
Label Claim ◽  
Development And Validation ◽  
Dextromethorphan Hydrobromide ◽  
Good Agreement

A simple, rapid and economic UV spectrophotometric method has been developed and validated using a solvent 0.1N HCl to determine Dextromethorphan hydrobromide content in bulk and two different pharmaceutical solid dosage formulations, lozenges and chewable tablets. At the pre-determined λmax of 278 nm, it was proved linear in the range of 5.0-30.0 µg/ml and exhibited good correlation coefficient (R2=0.9993) and excellent mean recovery (101.37-100.76%) and (100.66-101.17%) for lozenges and chewable tablets respectively. This method was successfully applied to the determination of Dextromethorphan hydrobromide content in lozenges and chewable tablets and the results were in good agreement with the label claim. The method was validated as per ICH guidelines for linearity, precision, accuracy, specificity, LOD and LOQ. The obtained results proved that the method can be employed for the routine analysis of Dextromethorphan hydrobromide in bulks as well as in the pharmaceutical formulations.

UV Spectrophotometric Method Development and Validation of Luliconazole in Bulk and Formulation

2021 ◽  
pp. 3826-3828
Author(s):  
Anuja Suryawanshi ◽  
Afaque Ansari ◽  
Mallinath Kalshetti
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Ich Guidelines ◽  
Water As Solvent ◽  
Method Development And Validation ◽  
Repeatability And Reproducibility ◽  
Uv Visible ◽  
Development And Validation ◽  
Dosage Formulation ◽  
Good Agreement

Objective: A new, simple, economical, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the estimation of luliconazole in pure form and pharmaceutical formulation as per ICH guidelines. Method: A UV spectrophotometric method has been developed using methanol and water as solvent to determine the luliconazole in bulk and pharmaceutical dosage formulation. The λmax of luliconazole in methanol and water was found to be 297nm. Results: The drug was proved linear in the range of 3-15µg/ml and exhibited good correlation coefficient (R2= 0.9993) and excellent mean recovery (98-99%). The % RSD for intra-day and inter-day precision was found to be 1.051288 and 1.138658 respectively. The LOD and LOQ of Luliconazole was found to be 1.1168µg/ml and 3.3845µg/ml respectively. This method was successfully applied to luliconazole content in marketed brands and results were in good agreement with the label claims. Conclusion: The method was validated for linearity, precision, repeatability and reproducibility. The obtained results proved that the method can be employed for the routine analysis of luliconazole in bulks as well as in commercial formulations.

UV spectroscopic method for determination of phenytoin in bulk and injection forms

2019 ◽  
Author(s):  
Chem Int
Keyword(s):  
Quality Control ◽  
Spectrophotometric Method ◽  
Spectroscopic Method ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Routine Quality Control

Recent study was conducted to develop a simple UV spectrophotometric method to determine Phenytoin in bulk and injection form according to official requirement and validate as per ICH guidelines. λmax of Phenytoin was found 202 nm. Linearity existed perceived in the concentration assortment 2-8 μg/ml (r2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The existent method was establish to be simple, linear, precise, accurate as well as sensitive and can be applied for routine quality control enquiry for the analysis of Phenytoin in bulk and injection form.

Azithromycin nanosuspension preparation using evaporative precipitation into aqueous solution (EPAS) method and its comparative dissolution study

2020 ◽  
Vol 17 ◽  
Author(s):  
Mohammad Hossain Shariare ◽  
Tonmoy Kumar Mondal ◽  
Hani Alothaid ◽  
Md. Didaruzzaman Sohel ◽  
MD Wadud ◽  
...  
Keyword(s):  
Aqueous Solution ◽  
Particle Size ◽  
Dissolution Rate ◽  
Average Particle Size ◽  
Scale Up ◽  
Average Particle ◽  
Total Drug ◽  
Residual Solvent ◽  
Dissolution Study ◽  
Drug Content

Aim: EPAS (evaporative precipitation into aqueous solution) was used in the current studies to prepare azithromycin nanosuspensions and investigate the physicochemical characteristics for the nanosuspension batches with the aim of enhancing the dissolution rate of the nanopreparation to improve bioavailability. Methods: EPAS method used in this study for preparing azithromycin nanosuspension was achieved through developing an in-house instrumentation method. Particle size distribution was measured using Zetasizer Nano S without sample dilution. Dissolved azithromycin nanosuspensions were also compared with raw azithromycin powder and commercially available products. Total drug content of nanosuspension batches were measured using an Ultra-Performance Liquid Chromatography (UPLC) system with Photodiode Array (PDA) detector while residual solvent was measured using gas chromatography (GC). Results: The average particle size of azithromycin nanosuspension was 447.2 nm and total drug content was measured to be 97.81% upon recovery. Dissolution study data showed significant increase in dissolution rate for nanosuspension batch when compared to raw azithromycin and commercial version (microsuspension). The residual solvent found for azithromycin nanosuspension is 0.000098023 mg/ mL or 98.023 ppb. Conclusion: EPAS was successfully used to prepare azithromycin nanoparticles that exhibited significantly enhanced dissolution rate. Further studies are required to scale up the process and determine long term stability of the nanoparticles.

scholarly journals UV SPECTROPHOTOMETRIC ANALYSIS AND VALIDATION OF OSELTAMIVIRPHOSPHATE IN PURE AND PHARMACEUTICAL FORMULATION

2020 ◽  
pp. 111-114 ◽  
Author(s):  
SACHIN A. YANJANE ◽  
SHRISHAIL M. GHURGHURE ◽  
VINOD K. MATOLE
Keyword(s):  
Spectrophotometric Method ◽  
Spectrophotometric Analysis ◽  
Pharmaceutical Formulation ◽  
Ich Guidelines ◽  
Highly Sensitive ◽  
Double Beam ◽  
Recovery Study ◽  
Uv Visible ◽  
Oseltamivir Phosphate ◽  
Simple Economic

Objective: A new, simple, economical, precise, sensitive, linear, accurate, rapid UV spectrophotometric method has been developed for the estimation of Oseltamivir Phosphate in pure form and pharmaceutical formulation. Methods: This UV method was developed using Methanol as a solvent. In the present method, the wavelength selected for analysis was 218 nm. UV-Visible double beam spectrophotometer (Systronic 2201) was used to carry out spectral analysis. The ICH guidelines were used to validate the method. Results: The method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was found in the range of 10-50µg/ml. Accuracy was performed by using a recovery study. The amount of drug recovered was found to be in the range of 99.01-100.1%. The % RSD value was found to be less than 2. Conclusion: The developed UV spectrophotometric method was found to be simple, economic, sensitive, easy, accurate, linear, specific and highly sensitive and can be used for routine estimation of Oseltamivir Phosphate.

Formulation and invitro evaluation of delayed release multiple unit pellets of Lansoprazole in capsules

2021 ◽  
pp. 2625-2630
Author(s):  
Suresh Kolli ◽  
K. Vijayasri ◽  
P.N. Murthy
Keyword(s):  
Acidic Environment ◽  
Drug Content ◽  
Delayed Release ◽  
Accelerated Stability ◽  
Ich Guidelines ◽  
Compressibility Index ◽  
Release Studies ◽  
Enteric Polymer ◽  
Multiple Unit ◽  
Tapped Density

The present research was aimed to formulate and evaluate Lansoprazole delayed release multiple unit pellets in capsules. Lansoprazole degrades in the acidic environment of the stomach. It is also unstable under conditions of high temperature and high humidity which leads to therapeutic inefficiency. Hence it is important to bypass the acidic pH of the stomach. Protection of drug from acidic environment is done by coating the drug with enteric polymer. In the present study, successive layers of drug layer, barrier layer and enteric layer was coated on the inert sugar spheres by using solution/suspension layering technique in Fluidized bed processor (FBP). The prepared drug layered and barrier layered pellets were evaluated for % yield. The prepared lubricated pellets were evaluated for flow properties i.e., bulk density, tapped density, compressibility index and hausner’s ratio. Lubricated pellets filled into size ‘1’ capsules and evaluated for drug content, drug content resisted in acid, invitro drug release studies and compared with the marketed product. The dissimilarity and similarity factors for the optimized and marketed formulations were found to be 84.29. Accelerated Stability Testing (AST) was performed as per the ICH guidelines at 40±5°C/75±5% RH for 6 months and found satisfactory.

HPLC METHOD DEVELOPMENT FOR ESTIMATION OF RAMELTEON IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 20-23
Author(s):  
S Sahoo ◽  
◽  
P. K. Panda ◽  
S. K. Mishra
Keyword(s):  
Flow Rate ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Tablet Dosage ◽  
Good Agreement

A simple, fast, accurate and precise reverse phase HPLC method is developed and described for the determination of ramelteon in tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and phosphate buffer pH 7.0 (35:65 V/V) as the mobile phase at a flow rate of 1.0 mL/min with detection at 286 nm. The retention time of the drug was 7.7 min. The procedure was validated for linearity, precision, accuracy, and robustness. The developed method was validated for linearity from 50 to 150% which shows the method is quite linear with a correlation coefficient of 0.999, for precision which includes system precision, method precision, intraday and by another analyst on another day, and accuracy. The %RSD for system precision was observed to be 1.1, whereas the method precision was observed to be 0.2. The % recovery from ‘accuracy’ studies yielded the recovery of 99.7-101.5% which indicates the capability of the method, and finally for robustness that includes studies w.r.t. change in flow rate, the percentage of organic modifier and pH. As per ICH guidelines, method validation results are in good agreement. The proposed method was simple, sensitive, precise and accurate.

Development and Validation of UV-Visible Spectrophotometric method for the Estimation of Curcumin and Tetrahydrocurcumin in Simulated Intestinal Fluid

2021 ◽  
pp. 2971-2975
Author(s):  
Jai Bharti Sharma ◽  
Sherry Sherry ◽  
Shailendra Bhatt ◽  
Vipin Saini ◽  
Manish Kumar
Keyword(s):  
Drug Release ◽  
Spectrophotometric Method ◽  
Tween 80 ◽  
Solvent System ◽  
Intestinal Fluid ◽  
Simulated Intestinal Fluid ◽  
Validation Parameters ◽  
Administration Method ◽  
Uv Visible ◽  
Development And Validation

Background: Due to solubility issues of curcumin and tetrahydrocurcumin, there is a need for the development of a UV-Visible spectrophotometric method that can estimate the drug release precisely and accurately. The addition of surfactant in the dissolution medium in low concentration achieved bio-comparable surface activity and can be used to estimate the drug release from formulations by avoiding sink conditions. Objective: The purpose of the present investigation was to develop a simple and précise UV-Visible spectrophotometric method for the determination of curcumin and tetrahydrocurcumin after oral administration. Method: A UV-Visible spectrophotometric method was developed using an appropriate solvent system for the estimation of curcumin and tetrahydrocurcumin. The solvent system having simulated intestinal fluid and particular concentration of surfactant was selected and further validated according to guidelines of the international conference on harmonization (ICH), the analytical parameter like linearity, precision and accuracy, etc. were studied. Results: Simulated intestinal fluid pH 7.4 with tween 80 at 1 % concentration satisfied all the conditions relative to peak quality at the stated wavelength for curcumin and intestinal fluid pH 7.4 with tween 80 at 0.5% concentration satisfied all the conditions relative to Peak quality at the stated wavelength for tetrahydrocurcumin. The developed methods were found within the range of all the validation parameters. Conclusion: The proposed method was found to be very simple and precise and can be used for routine quantitative analysis of curcumin and tetrahydrocurcumin.

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