scholarly journals Quantitative Determination of Ephedrine Hydrochloride in Pharmaceutical Injections by Highly Sensitive Turbidimetric and Reversed-Phase Combined with UFLC Methods

2019 ◽  
Vol 13 (2) ◽  
pp. 269-274
Author(s):  
Jalal N. Jeber ◽  
Keyword(s):  
Quantitative Determination ◽  
Reversed Phase ◽  
Ephedrine Hydrochloride ◽  
Highly Sensitive

scholarly journals Development and Validation of an UHPLC Method for Ostarine Determination in Dietary Supplements

2019 ◽  
Vol 65 (2) ◽  
pp. 49-54
Author(s):  
Amalia Miklos ◽  
Amelia Tero-Vescan ◽  
Lénárd Farczádi ◽  
Daniela-Lucia Muntean
Keyword(s):  
Quantitative Determination ◽  
Dietary Supplements ◽  
Low Cost ◽  
Reversed Phase ◽  
European Pharmacopoeia ◽  
Average Mass ◽  
7Th Edition ◽  
Development And Validation ◽  
Mg Content

AbstractObjective: The purpose of this study was to develop a low-cost, yet sensitive and precise UHPLC method for the quantitative determination of ostarine from dietary supplements (DS) for athletes. The analytical performance of the method was verified on a DS legally acquired from a specialized website for athletes. The uniformity of mass and content of the ostarine DS was also verified.Methods: For the quantitative determination of ostarine a UHPLC method was developed and validated. The separation was performed using a reversed-phase C18 column, using a mixture of 75% methanol: 25% formic acid 0.1% in isocratic elution, at a flow rate of 0.5 ml/min. The uniformity of mass and content of DS was performed following the methodology described in the European Pharmacopoeia 7th Edition.Results: The validated method was specific and linear on the concentration range of 1-25 µg/ml and was precise and accurate at all concentration levels, according to the official guidelines for validating analytical methods. An average mass of 510 mg content was obtained for the ostarine capsules, with an RSD of 2.41%. Regarding the uniformity of the content, an average of 4.65 mg ostarine/capsule was obtained with an RSD of 1.05%.Conclusions: The developed UHPLC method was suitable, rapid, sensitive and allowed quantitative determination of active substance content in a DS with ostarine (92.91% ostarine/capsule from 5 mg ostarine/capsule declared by the manufacturer).

Specific and Sensitive RP-HPLC Method Development and Validation for the Determination of Aripiprazole: Application in Preformulation Screening of Nanoemulsion

2020 ◽  
Vol 10 (1) ◽  
pp. 76-86 ◽  
Author(s):  
Santosh A. Kumbhar ◽  
Chandrakant R. Kokare ◽  
Birendra Shrivastava ◽  
Hira Choudhury
Keyword(s):  
Quantitative Determination ◽  
Method Development ◽  
Developmental Stages ◽  
Reversed Phase ◽  
Hplc Method ◽  
Least Square ◽  
Formulation Development ◽  
Linear Calibration ◽  
Rp Hplc

Background: It has been hypothesized that delivery of aripiprazole through nanoemulsion formulation would better deliver the drug into the central nervous system to treat major depressive conditions in psychological patients. Due course of formulation development, to determine solubility of the drug in different matrices and nanoemulsion is an important step. Materials & Methods: Therefore, a simple, rapid and selective reversed phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of aripiprazole as per International Conference of Harmonization (ICH) guidelines. Satisfactory analysis method was employed for the quantitative determination of aripiprazole during pre-formulation development. Results and Discussion: The separation technique was achieved using the mobile phases of methanol-acetonitrile, 80:20 (v/v) delivered at 1.0 mL.min-1 flow rate through HIQ SIL C18 250x4.6 mm (5 μm particle size) column and detected at 218 nm wavelength. The method depicted linear calibration plots within the range of 5 to 50 µg.mL-1 with a determination coefficient (r2) of 0.9991 calculated by least square regression method. The validated method was sensitive with LOD of 10.0 ng.mL-1 and 30.0 ng.mL-1 of LOQ. The intra-day and inter-day precision values were ranged between 0.37-0.89 and 0.63-1.11 respectively, with accuracy ranging from 98.24 to 100.88 and 97.03 to 100.88, respectively. This developed and validated method was found to be sensitive for the determination of aripiprazole for the first time from various oils, surfactants, co-surfactants, and nanoemulsion formulation. Conclusion: This RP-HPLC method was successfully implemented for the quantitative determination of aripiprazole at developmental stages of nanoemulsion formulation.

Chromatographic Study of Azintamide in Bulk Powder and in Pharmaceutical Formulation in the Presence of Its Degradation Form

2017 ◽  
Vol 100 (2) ◽  
pp. 422-428 ◽  
Author(s):  
Maha A Hegazy ◽  
Waleed A Hassanain ◽  
Laila E Abdel Fattah ◽  
Hamed M El-Fatatry
Keyword(s):  
Quantitative Determination ◽  
Degradation Product ◽  
Internal Standard ◽  
Reversed Phase ◽  
Pharmaceutical Formulation ◽  
Chromatographic Study ◽  
Significant Difference ◽  
Tlc Plates ◽  
Acidic Degradation

Abstract Two specific, sensitive, and precise stability-indicating chromatographic methods were developed, optimized, and validated for the determination of Azintamide (AZ) in the presence of its degradation product. The first method was TLC combined with the densitometric determination of the separated bands. Separation was achieved using silica gel 60 F254 TLC plates and chloroform–acetone–glacial acetic acid (7.5 + 2.1 + 0.4, v/v/v) as the developing system. Good correlations were obtained between the integrated peak area of the studied drug and its corresponding concentrations in the linearity range. The second method used HPLC with UV diode-array detection, in which the proposed method was applied for the quantitative determination of AZ in the presence of its acidic degradation product and the quantitative determination of the acid-induced degradation product of AZ (AZ Deg) using pentoxifylline as the internal standard. The proposed components were separated on a reversed-phase C18 analytical column using acetonitrile–water (50 + 50, v/v). The flow rate was maintained at 0.55 mL/min and the detection wavelength was 260 nm. Linear regressions were obtained in the range of 1–30 and 0.3–16 μg/mL for AZ and AZ Deg, respectively. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. The suggested methods were validated in compliance with the International Conference on Harmonization guidelines and successfully applied for the determination of AZ in its pure powder form and in its pharmaceutical formulation. Both methods were also statistically compared with the reported method with no significant difference in performance observed.

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