scholarly journals Analytical Method development and Validation of Lamivudine in Formulation by using Reversed Phase Ultra Performance Liquid Chromatography

2020 ◽  
Vol 13 (2) ◽  
pp. 1-6
Author(s):  
Anshul kumar ◽  
Chandana Majee ◽  
Vivek Namdev
Keyword(s):  
Method Development ◽  
Ultra Performance Liquid Chromatography ◽  
Reversed Phase ◽  
Array Detector ◽  
Solution Stability ◽  
Solution Stability And Robustness ◽  
Acquity Uplc ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Aim of the experiment was to develop a simple, specific and accurate reverse phase ultra-performance liquid chromatographic (UPLC) method for the determination of lamivudine in the tablet dosage forms. The chromatographic separation was achieved on Acquity UPLC HSST3 (2.1 x 100mm) 1.8 um particle size and the mobile phase containing 0.1%TFA: MeOH for lamivudine. The run time was 10 min and the retention time of lamivudine was about 4.6. The detection was carried out 215nm using photo diode array detector (PDA) with a flow rate 0.6 ml/min. The linearity of lamivudine with correlation coefficient 0.9998. The recovery was found in the range (100±10%). The developed method was validated as per International Conference on Harmonization guidelines (ICH) with respect to specificity, linearity, accuracy, method precision, system precision, solution stability and robustness

scholarly journals Analytical method development and validation of assay test of pravastatin sodium tablets

2019 ◽  
Vol 9 (2) ◽  
pp. 70-75
Author(s):  
Ashvini C Shinde ◽  
Nitin V Devhadrao ◽  
Ashwini S Bansode ◽  
Ajit S Bansode
Keyword(s):  
Mobile Phase ◽  
Method Development ◽  
Solution Stability ◽  
Pravastatin Sodium ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Acquity Uplc ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise and stability indicating Ultra performance liquid chromatographic method for determination of pravastatin sodium in tablet dosage form. The separation was carried on Acquity UPLC ® HSS C18, 2.1 × 100mm, 1.8µm ID column, with mobile phase comprising of mixture of pH 5.5 buffer: methanol in the ratio of 30 : 70 v/v, as the mobile phase at a flow rate  0.2 ml/min and the detection was carried out using UV-visible detector at 238nm. The method was validated by evaluation of different parameters such as accuracy, precision, linearity, ruggedness, robustness, filter equivalency, solution stability. The retention time were found to be 1.5 min. Calibration curves were linear with correlation coefficient (r2) 0.999. The Percent assay of Pravastatin sodium tablet was found to be 98.4%. The developed methods were validated as per the ICH guidelines. Keywords: Pravastatin sodium (PVS), UPLC, Method Validation.

scholarly journals Method Development and Validation for The Simultaneous Estimation of Levofloxacin and Cefpodoxime Proxetil by Using RP-HPLC in Combined Tablet Dosage Form

2014 ◽  
Vol 11 (1) ◽  
pp. 67-73 ◽  
Author(s):  
Kole Spandana ◽  
Ch. Rathnakar ◽  
Kole Bhavana
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Column Temperature ◽  
Cefpodoxime Proxetil ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

An isocratic, reversed phase-liquid-chromatographic method was developed for the quantitative determination of Levofloxacin and Cefpodoxime proxetil in combined-dosage form. Alliance -Waters System with Agilant Zorbax Eclipse XBD-C8, (150mm×4.6; 5µm) column with mobile phase containing water with Ortho phosphoric acid: Methanol in the ratio of (80: 20, v/v) was used. The flow rate was 0.5 ml/min, column temperature was 40°C and effluents were monitored at 270 nm. The retention times of Levofloxacin and Cefpodoxime proxetil were 3.096min and 4.559min, respectively. The correlation co-efficient for Levofloxacin and Cefpodoxime proxetil was found to be 1.0 and 1.0, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of Levofloxacin and Cefpodoxime proxetil in formulations was found to be in the range of 97-103% and 97-103% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and high precision. The method was successfully applied for the estimation of Levofloxacin and Cefpodoxime proxetil in combined dosage form.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ABACAVIR SULPHATE AND LAMIVUDINE IN TABLET DOSAGE FORM BY RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 12-16
Author(s):  
S Vidyadhara ◽  
◽  
L. S Reddyvalam ◽  
T. Koduri ◽  
P. K. Borra ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Correlation Coefficients ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise high-performance liquid chromatographic (HPLC) method has been developed and validated for the simultaneous determination of abacavir sulphate (ABA) and lamivudine (LAM) in combined dosage form. Separation was performed on a C18 column [Agilent ODS UG 5 column, 250 mm x 4.5 mm], with methanol: water (50:50 V/V) isocratic elution using a flow rate of 1mL/min. Good sensitivity was observed with UV detection at 277 nm. After method development, the interference of other active compounds and excipients, repeatability and linearity, were investigated. Retention times of LAM and ABA were found to be 3.3 and 6.3 min, respectively. The method was validated over the range from 2.5-12.5 μg/mL for LAM and 5-25 μg/mL for ABA with correlation coefficients of 0.9997 and 0.9996, respectively. This method was shown to be accurate, robust, selective, linear, and repeatable and can be successfully employed in routine quality control for the simultaneous analysis of ABA and LAM in tablets.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF LOPINAVIR IN TABLET DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2018 ◽  
Vol 11 ◽  
Author(s):  
Sunkara Namratha ◽  
Vijayalakshmi A
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: Reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed for the assessment of lopinavir in the dosage form of tablet.Methods: Chromatogram was run through using Kromosil C18 4.5×150 mm using a mobile phase methanol: water of ratio 65:35% v/v with a rate of flow of 0.8 ml/min, measured by UV spectrometric detection at 265 nm. The method developed was validated in terms of precision, accuracy, linearity, and robustness parameters.Results: Retention time of lopinavir established at 2.482 min and percentage R.S.D of lopinavir found to be 1.0% and 0.5%, respectively. The method shows that good linearity range of 30–150 μg correlation coefficient of lopinavir was 0.997. The limit of detection was 2.97 and limit of quantification was 9.92, respectively. The percent purity of lopinavir was 99.87%.Conclusion: The suggested method (Rp-HPLC) for concurrent assay lopinavir was validated, which is appropriate method for the analysis oflopinavir quantitatively in tablet dosage forms and bulk.

scholarly journals Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

2020 ◽  
Vol 10 (4) ◽  
pp. 97-101
Author(s):  
Mithun Rudrapal ◽  
Nazim Hussain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Average Percentage ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

scholarly journals Method development and validation for simultaneous estimation of amlodipine besylate and enalapril maleate in solid dosage form

2021 ◽  
Vol 8 (3) ◽  
pp. 129-133
Author(s):  
Manisha Masih
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Solution Stability ◽  
Amlodipine Besylate ◽  
Enalapril Maleate ◽  
Solid Dosage ◽  
Development And Validation ◽  
Liquid Chromatographic

A rapid, sensitive, specific, accurate and precise high pressure liquid chromatographic method (HPLC) method involving UV detection has been developed for the determination and quantification of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form. The determination was carried out on a Phenomenex C18 column (Dimention : 250 x 4.6 mm, 5 μm). The sample was analysed using filtered and degassed mixture of methanol : 0.1N HCl (1:1) as mobile phase at a flow rate of 1ml/min and effluent was monitored at 218nm. The retention time for Amlodipine besylate was 7.6 min and for Enalapril maleate 3.2 min. Amlodipine besylate and Enalapril maleate showed a linear response in the concentration range of 10-50μg/ml. The correlation co-efficient ('r' value) for Amlodipine besylate and Enalapril maleate was 0.9992 and 0.9994, respectively. The method was validated in terms of linearity, precision, accuracy, specificity, robustness and solution stability. The proposed method can be used for routine analysis of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form

Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

2021 ◽  
pp. 4767-4772
Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Solution Stability ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE AND DICYCLOMINE HYDROCHLORIDE IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (4) ◽  
pp. 78-81
Author(s):  
Rajesh Sharma ◽  
◽  
Mukesh C. Sharma ◽  
Gaurav Vijaywargiya
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Water Ph ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic ◽  
Clidinium Bromide

A simple, specific, accurate reversed phase high performance liquid chromatographic method was developed for the simultaneous estimation of clidinium bromide, chlordiazepoxide and dicyclomine hydrochloride. Chromatographic separation of the three drugs was performed on a Chromatopak C-18 column (25 cm x 4.6 i.d. x 5µm) as the stationary phase with a mobile phase composed of 0.1 % triethylamine in water pH adjusted by 5 % o-phosphoric acid and acetonitrile in the ratio 30:70 at a flow rate of 0.8mL/min, Detection was carried out at 210 nm. The retention times of clidinium bromide, chlordiazepoxide and, dicyclomine hydrochloride were found to be 3.9 min, 5.4 min, and 6.8 min, respectively. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ.

scholarly journals Method development and validation for Cabotegravir and Rilpivirine by using HPLC and its degradants are characterized by LCMS and FTIR

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Anuradha Vejendla ◽  
Subrahmanyam Talari ◽  
Raju Moturu ◽  
S. N. Murthy Boddapati ◽  
A. Emmanuel Kola
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Array Detector ◽  
Forced Degradation ◽  
Current Application ◽  
Pharmaceutical Ingredients ◽  
Photodiode Array Detector ◽  
Development And Validation ◽  
Liquid Chromatographic

Abstract Background Using a Symmetry C18 (4.6 × 150 mm, 3.5) column, a high-performance liquid chromatographic method for quantification of Rilpivirine and Cabotegravir in active pharmaceutical ingredients was developed and validated. The mobile phase is made up of buffer, acetonitrile, and 0.1 percent formic acid in a 20:80v/v ratio. The flow rate was kept constant at 1.0 ml/min, and detection was accomplished through absorption at 231 nm with a photodiode array detector. Results The calibration curve was linear, with a regression coefficient (R2) value of 0.999 and concentrations ranging from 30 to 450 g/ml of Rilpivirine and 20–300 g/ml of Cabotegravir. The method's LOD and LOQ were 0.375 g/ml, 1.238 g/ml, and 0.25 g/ml, 0.825 g/ml for Rilpivirine and Cabotegravir, respectively. Conclusions In the forced degradation studies, the degradants were characterized by using LCMS and FTIR. The current application was found to be simple, economical, and suitable, and validated according to ICH guidelines.

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