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 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 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.

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 Stability Demonstrating Validated High Pressure Liquid Chromatographic Method for the Determination of Trilaciclib in Bulk and Pharmaceutical Formulation

2021 ◽  
pp. 173-181
Author(s):  
Syed. Rafi ◽  
Kantipudi Rambabu
Keyword(s):  
Andhra Pradesh ◽  
Wave Length ◽  
High Pressure Liquid Chromatographic ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Formulation Analysis ◽  
College Of Engineering ◽  
Liquid Chromatographic ◽  
Mathematical Process

Aims: New validated method for the estimation of  Trilaciclib using HPLC and study of its degradation Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021. Methodology: Using an inertsil ODS column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (50:50 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 220 nm. Trilaciclib had a retention time of 4.358 minutes. The isocratic chromatography was performed at room temperature and took approximately six minutes to complete. Results: Analysis was achieved within 6 min over an honest linearity within the concentration range from 3-45 µg/ml of Trilaciclib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.038 μg/ml and 0.124 g/ml for trilaciclib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.

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.

UV Spectrophotometric Analysis and Validation of Dapsone in Semisolid Dosage Form

2021 ◽  
pp. 5007-5009
Author(s):  
Gajanand Nangare ◽  
Varsha Tegeli ◽  
Suyash Ingle ◽  
Vinod Matole ◽  
Avinash Birajdar ◽  
...  
Keyword(s):  
Dosage Form ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Spectrophotometric Analysis ◽  
Ich Guidelines ◽  
Double Beam ◽  
Recovery Study ◽  
Uv Visible ◽  
Routine Assay ◽  
Stable Linear

Objectives: A new, economical, sensitive, simple, rapid UV spectrophotometric method has been developed for the estimation of Dapsone in pure form and Semisolid Dosage form. Method: This UV method was developed using methanol: RO water (75:25) as a solvent. In the present method the wavelength selected for analysis was 260nm. 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 3-18µg/ml. Accuracy was performed by using recovery study. The amount of drug recovered was found to be in the range of 100.1-100.5 %. The %RSD value was found to be less than 2. Conclusion: The proposed UV spectroscopic method was found to be accurate, precise, stable, linear, specific, and simple for quantitative estimation of Dapsone in bulk and Semisolid dosage form. Hence the present UV spectroscopic method is suitable for routine assay of Dapsone in bulk and Semisolid dosage form.

Theophylline Determination in Pharmaceuticals Using a Novel High-performance Liquid Chromatographic Process

2021 ◽  
Vol 19 (7) ◽  
pp. 196-208
Author(s):  
H.N.K. AL-Salman ◽  
Ekhlas Qanber Jasim ◽  
Hussein H. Hussein
Keyword(s):  
High Performance ◽  
Orthophosphoric Acid ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
International Conference ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Chromatographic Process ◽  
Liquid Chromatographic

Objective: The current study aims to find a suitable, accurate, and faster RP-HPLC technique for the determination of theophylline, which could then be validated in accordance with the International Conference on Harmonization (ICH) guidelines. The Aim of this Study: The aim of this study was to develop an efficient, accurate, and faster RP-HPLC method for determining theophylline, which was then validated using the International Conference on Harmonization (ICH) guidelines. Methods: In the HPLC analysis, the Waters 2695 was used. The drug was isolated better using an Ion Pac zorbax 300-SCX Agilent Column, 5 m, 4.6 250 mm, with a liquid phase of Orthophosphoric acid (0.1 percent Orthophosphoric acid in HPLC acetonitrile and Methanol in the ratio of 50:50 v/v at a flow rate of 1ml/min, with discovery at 280 nm using a PDA detector. Results: Theophylline's preservation time was discovered to be 3.747 0.127 min. In the 5-25 mg/l range, the procedure was found to be linear, with a parallel coefficient (R2) of 0.9998. The LOD and LOQ of the system were determined to be (0.99 and 3) g/ml, respectively. The technique and system precisions were predicted using, and the outcomes were determined as percent RSD principles, which were noticed to be within the strict limitations. Theophylline recovery was detected to be in the 99-100 percent range, confirming the method's precision. Conclusion: Using basic ICH guidelines, the suggested RP-HPLC process was validated. The following methodology can be used successfully and easily for routine diagnostic analysis.

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 Simultaneous Spectrophotometric Determination of Paracetamol, Propyphenazone and Caffeine By Using Absorption Ratio Method

2018 ◽  
Vol 6 (5) ◽  
pp. 5-8
Author(s):  
Ainil Fithri Pulungan ◽  
Effendy DLP. ◽  
Siti MS.
Keyword(s):  
Spectrophotometric Determination ◽  
Ratio Method ◽  
Tablet Form ◽  
Separation Stage ◽  
International Conference ◽  
Absorption Ratio ◽  
Ich Guidelines ◽  
Drug Compound

The Absorption Ratio method involves measuring the absorbance at two wavelengths, namely the iso-absorptive point and the maximum wavelength. Its method could be an option in determining the level of a drug. The aim of this study was to determine whether the absorption ratio method can be used to determine the levels of paracetamol (PCT), propyphenazone (PRO) and caffeine (CAF) in tablet form. The absorption ratio method was used to determine the levels of the mixed drug compound without the separation stage and using the maximum wavelength and iso-absorptif point. The result of the study showed that the absorption ratio method used to solve multicomponent problems in tablet form can be performed and satisfy the validation requirements of the method according to international Conference on Harmonization Q2 (R1) (ICH) guidelines. The absorption ratio method was a simple and accurate to be used determine PCT, PRO, CAF in tablet form. Keywords : Paracetamol, propyphenazone, caffeine, absorption ratio

Method Development and Validation of UV Spectrophotometric Method for the Quantitative Estimation of Curcumin in Simulated Nasal Fluid

Drug Research ◽  
2020 ◽  
Vol 70 (08) ◽  
pp. 356-359
Author(s):  
Sherry Sharma ◽  
Jai Bharti Sharma ◽  
Shailendra Bhatt ◽  
Manish Kumar
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Quantitative Estimation ◽  
Tween 80 ◽  
Solvent System ◽  
Control Analysis ◽  
Double Beam ◽  
Uv Visible ◽  
Therapeutic Activities ◽  
Nasal Fluid

Abstract Background Curcumin is a polyphenolic compound with numerous therapeutic activities. There is no validated method available for the quantitative estimation of curcumin in simulated nasal fluid. Objective The aim of present investigation was to develop a simple and precise UV visible spectrophotometric method for estimation of pure form of curcumin in simulated nasal fluid. Method Suitable solvent system was selected by estimation of curcumin at UV maxima of 421nm in simulated nasal fluid with two surfactants (tween 80 and sodium lauryl sulphate). The double beam UV visible spectrophotometer was used for measurement of absorption. The selected solvent system was further validated according to guidelines of international conference on harmonization (ICH), the analytical parameter like linearity, precision and accuracy etc. were studied. Results Simulated nasal fluid with tween 80 at 1% concentration satisfied all the conditions relative to Peak quality at the stated wavelength. In developed method, curcumin was found to be linear over selected concentration range of 5 to 60µg/ml with a correlation coefficient of 0.998. The accuracy was found to be in range of 99.51 –100.223%.The precision was found to be less than 2 in terms of % RSD. The LOD & LOQ were 0.3657 & 1.109 respectively. Conclusion The proposed method was found to be simple, sensitive and precise. The most important this method can be used for routine quality control analysis of curcumin with accuracy.

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