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

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 Analytical quality by design approach to RP-HPLC method development and validation for simultaneous estimation of esomeprazole and naproxen in modified-release dosage form

2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Khandokar Farjana Urmi ◽  
Md. Saddam Nawaz ◽  
S. M. Ashraful Islam
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Quality By Design ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Solution Stability ◽  
Modified Release ◽  
Analytical Quality ◽  
Rp Hplc ◽  
Development And Validation

Abstract Background The present work describes the development and validation of a new, specific, accurate, and precise stability-indicating RP-HPLC method for the simultaneous estimation of Esomeprazole (ESP) and Naproxen (NAP) in modified-release bi-layer tablet dosage form. Analytical Quality by Design concept was implemented through the method development exercise to establish the robustness of the method. Results Method development was performed on C18, 250 × 4.6 mm ID, and 5 µm particle size column with 10 µl injection volume using a photodiode array (PDA) detector to monitor the detection at 280 nm. The mobile phase consisted of the buffer: methanol at a ratio of 50: 50 (v/v), and the flow rate was maintained at 1.5 ml/min, and the column oven temperature was maintained at 30 °C. The retention times for NAP and ESP were found 5.9 ± 0.1 and 8.9 ± 0.1 min, respectively. The method was validated in terms of system suitability, specificity, accuracy, linearity, precision, and solution stability. Linearity was observed over the range of concentration 8–12 µg/ml for ESP and 200–300 µg/ml for NAP, and the correlation coefficient (R2) was found excellent > 0.999. The method was specific to ESP and NAP, and the peak purity was found 99.97% for ESP and 100.00% for NAP. The method was precise and had %RSD less than 2. Recovery study for accuracy with placebo was found in the range of 99.63–100.36% for ESP and 99.91–100.43% for NAP. Conclusion This proposed fast, reliable, cost-effective method can be used as a quality control tool for the simultaneous determination of Esomeprazole and Naproxen in routine laboratory analysis. Graphical Abstract

scholarly journals New Analytical Method Development and Validation for Simultaneous Estimation of Sofosbuvir and Velpatasvir in Bulk and Pharmaceutical Dosage Form by RP-HPLC Method

2020 ◽  
Vol 10 (5) ◽  
pp. 143-148
Author(s):  
T. Hanuman ◽  
T. Sivakkumar ◽  
S. Sridhar
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sofosbuvir and Velpatasvirin pharmaceutical dosage form. The column used was Kromosil C18(150mm x 4.6 mm, 5mm)in isocratic mode, with mobile phase containing phosphate buffer andacetonitrile(70:30v/v). The buffer is prepared by adding 1.41gm of sodium dihyrogen ortho phosphate in a 1000ml of volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then pH adjusted to 3.5 with dil. orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 260 nm. The retention times of Sofosbuvir and Velpatasvirwere found to be 2.404min and 2.986 min, respectively. The linearity for Sofosbuvir and Velpatasvirwere in the range of 40-240µg/ml and 10-60 µg/ml respectively. The recoveries of Sofosbuvir and Velpatasvirwere found to be 99.64% and 99.25%, respectively. The proposed method was validated and successfully applied to the estimation of Sofosbuvir and Velpatasvirin combined tablet dosage forms. Keywords: Sofosbuvir, Velpatasvir, Validation, Buffer and ICH Guidelines.

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