scholarly journals Development and Validation of New High Performance Liquid Chromatography Analytical Technique For Separation of Diclofenac Sodium and Lidocaine Hydrochloride From Ampoule Injection

2020 ◽  
Vol 5 (1) ◽  
pp. 115-127
Author(s):  
Mohammed Ali Salih ◽  
Dlivan Fattah Aziz ◽  
Salar Ibrahim Ali
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Diclofenac Sodium ◽  
Lidocaine Hydrochloride ◽  
Working Standard ◽  
Pharmaceutical Dosage Form ◽  
Analytical Technique ◽  
Lidocaine Hcl

In the current investigation, a number of chromatographic methods with the accurate, precise and specific criteria have been developed and validated for diclofenac sodium and lidocaine hydrochloride Commitment of their large quantities ampule of pharmaceutical dosage form. The High-Performance Liquid Chromatography (HPLC) system was performed at 25 ° C; with appropriate chromatographic isolation accomplished through the use of Waters Symmetry SB-C7 column with a mobile phase containing 0.1 M sodium acetate and methanol (40:60) (v/v). During development the portable stage was delivered at a stream rate of 1 mL/min, the wavelength was adjusted at 254 nm. First of all, the retention times for diclofenac sodium and lidocaine HCl were about 4.1 and 10.8 min accordingly. A performance and technical demonstration of the suggested Revers phase-HPLC method has been numerically challenged with support to process appropriateness, verticality, scales, simplicity, repeatability, sensitivity, stability, discovery and limits of quantification. In addition, the calibration curves for diclofenac sodium active pharmaceutical ingredient (API) with linear regressions > 0,999895 obtained linear in the distances 1870-5600 μg / mL. Moreover, for determining of lidocaine HCl drug, a range of 500 - 1500 μg/mL of working standard was used, the result showed for lidocain HCl that a linear curve with correlation coefficients of > 0.99980. Finally, the both drugs were isolated and resolute with selective and stable characteristics by the proposed technique. In the conclusion, successful validation of the HPLC approach has been demonstrated with high precision and accuracy for the assessment of both the mixed dosage form type of both diclofenac sodium and lidocaine HCl.

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FIMASARTAN BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND PHARMACEUTICAL DOSAGE FORM

2021 ◽  
pp. 138-146
Author(s):  
SRUTHI A ◽  
UTTAM PRASAD PANIGRAHY
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Internal Diameter ◽  
Uv Detector ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

Objective: A rapid, sensitive and specific reverse phase High performance liquid Chromatography (RP-HPLC) method was developed for the estimation of Fimasartan in bulk and pharmaceutical dosage form. Method: The RP-HPLC analysis was performed isocratically on a Primacel C18 column (150 mm × 4.6 mm internal diameter, 5 μm particle size) using mobile phase of composition Acetonitrile and 0.1% orthophosphoric Acid in 80:20, v/v proportions with a flow rate of 0.8 ml/min. Results: The analyte was monitered with UV-detector at 265 nm. In the developed method Fimasartan elutes at a typical retention time of 2.4 min. The proposed method is having linearity in the concentration ranging from 5-30 μg/ml of Fimasartan. Conclusion: : The method was statistically validated and had been applied to analysis of the drug in bulk and pharmaceutical dosage form.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE RELATED SUBSTANCE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE‑PHASE – HIGH‑PERFORMANCE LIQUID CHROMATOGRAPHY

2018 ◽  
Vol 11 (10) ◽  
pp. 357
Author(s):  
Rajesh Nawale ◽  
Shankar Pol ◽  
Prashant Puranik ◽  
Anwar Daud ◽  
Vishal Rajkondawar
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Dabigatran Etexilate ◽  
Sample Solution ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Standard Solution

Objective: The objective of the study was to develop and validate new, simple, and selective reverse-phase–high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of Dabigatran Etexilate (DE) and its impurities in pharmaceutical dosage form as per the International Conference on Harmonization guidelines.Method: Chromatographic analysis was performed on Princeton SPHER-l00 C18 (250 × 4.6 mm, 5 μm) HPLC column, maintained at 50°C column temperatures, 6°C sample tray temperature, and detection monitored at 225 nm. The mobile phase consisted of acetonitrile:phosphate buffer (pH 2.5) (33:67 V/V). The flow rate was maintained at 1.0 ml/min.Results: The system suitability results indicate good performance of the system. Specificity study indicates that there is no interference of placebo and blank. The percentage relative standard deviation (RSD) of six preparations for known and unknown impurity in the sample solution is found below 10%; hence, the method is precise. The calibration curve for DE (unknown impurity), Impurity A was linear from 0.38 to 4.5 μg/ml (correlation coefficients [r2] for unknown Impurity [DE] and Impurity A are 0.996 and 0.999, respectively). The calibration curve for Impurity B and Impurity E was linear from 0.38 to 9.00 μg/ml (r2 for Impurity B and Impurity E are 0.999 and 0.999, respectively); hence, the method is linear. Accuracy for DE (unknown Impurity), Impurity A, Impurity B, and Impurity E are found within 80%–120%; hence, the method is accurate. The percentage RSD for a standard solution is found below 5% up to 24 h, and percentage impurity change in the sample solution is found below 0.1% up to 18 h; hence, standard solution is stable up to 24 h, and sample solution is stable up to 18 h.Conclusion: The developed method is new, simple, adequate, specific, precise, linear, and accurate for the determination of DE and its impurities in pharmaceutical dosage forms.

scholarly journals Determination of human growth hormone in pure and pharmaceutical dosage form by spectrofluorometry and high performance liquid chromatography

2012 ◽  
Vol 18 (3) ◽  
pp. 399-405 ◽  
Author(s):  
Bilal Yilmaz ◽  
Yucel Kadioglu ◽  
Kadem Meral ◽  
Yavuz Onganer
Keyword(s):  
Growth Hormone ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Human Growth Hormone ◽  
High Performance ◽  
Dosage Form ◽  
Human Growth ◽  
Pharmaceutical Dosage Form ◽  
Relative Standard

In this study, a new and rapid spectrofluorometry and high performance liquid chromatography (HPLC) methods were developed for determination of human growth hormone in pure and pharmaceutical dosage form. The solvent system, wavelength of detection and chromatographic conditions were optimized in order to maximize the sensitivity of both the proposed methods. The linearity was established over the concentration range of 1.25-50?g mL-1 for spectrofluorometry and 10-75?g mL-1 for HPLC method. The intra- and inter-day relative standard deviation (RSD) was less than 8.46 and 5.98% for spectrofluorometry and HPLC, respectively. Limits of quantitation were determined as 0.075 and 7.5?g mL-1 for spectrofluorometry and HPLC, respectively. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of commercial growth hormone dosage form to quantify the drug and to check the formulation content uniformity.

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