Structural Analysis and Quantitative Determination of Clevidipine Butyrate Impurities Using an Advanced RP-HPLC Method

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.

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Development and validation of an RP-HPLC method for quantitative determination of vanillin and related phenolic compounds inVanilla planifolia

Journal of Separation Science ◽

10.1002/jssc.200600193 ◽

2007 ◽

Vol 30 (1) ◽

pp. 15-20 ◽

Cited By ~ 44

Author(s):

Arun Kumar Sinha ◽

Subash Chandra Verma ◽

Upendra Kumar Sharma

Keyword(s):

Phenolic Compounds ◽

Quantitative Determination ◽

Hplc Method ◽

Rp Hplc ◽

Development And Validation

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Quantitative determination of ciprofibrate in tablets by derivative UV spectroscopy and RP-HPLC method

Indian Journal of Pharmaceutical Sciences ◽

10.4103/0250-474x.103855 ◽

2012 ◽

Vol 74 (2) ◽

pp. 168

Author(s):

PS Jain ◽

HN Jivani ◽

RN Khatal ◽

SJ Surana

Keyword(s):

Quantitative Determination ◽

Uv Spectroscopy ◽

Hplc Method ◽

Rp Hplc

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Quantitative estimation of trimazolin hydrochloride in pharmaceutical preparation by RP-HPLC method

Hemijska industrija ◽

10.2298/hemind0902087s ◽

2009 ◽

Vol 63 (2) ◽

pp. 87-93 ◽

Cited By ~ 2

Author(s):

Ivana Savic ◽

Goran Nikolic ◽

Vladimir Bankovic ◽

Ivan Savic

Keyword(s):

Phase Composition ◽

Quantitative Determination ◽

Mobile Phase ◽

Quantitative Estimation ◽

Pharmaceutical Preparation ◽

Hplc Method ◽

Mobile Phase Composition ◽

Rp Hplc ◽

Ich Guidelines

A sensitive and selective RP-HPLC method was developed and validated for the quantitative determination of trimazolin hydrochloride in nasal drops formulations. The mobile phase composition was water-acetonitrile (50:50, v/v) and the UV detection was carried out at 270 nm. Linearity range in the concentration range of 10 to 110 ?g cm-3. The method was tested and validated for various parameters according to ICH guidelines. The detection and quantization limits were found to be 1.45 and 4.8 ?g cm-3, respectively. The results demonstrated that the procedure for estimation of trimazolin hydrochloride in nasal drops formulations was accurate, precise and reproducible.

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Development and validation of an RP-HPLC method for the simultaneous determination of total withanolide glycosides and Withaferin A in Withania somnifera (Ashwagandha)

Current Chromatography ◽

10.2174/2213240607999200813194349 ◽

2020 ◽

Vol 7 (2) ◽

pp. 106-120

Author(s):

Benny Antony ◽

Merina Benny ◽

Binu T. Kuruvilla ◽

Anu Sebastian ◽

Anu Aravind Aravindakshan Pillai ◽

...

Keyword(s):

High Performance Liquid Chromatography ◽

Quantitative Determination ◽

High Performance ◽

Withania Somnifera ◽

Reversed Phase ◽

Hplc Method ◽

Withaferin A ◽

Rp Hplc ◽

Ich Guidelines

Background:: Withanolide glycosides in Ashwagandha (Withania somnifera), are important metabolites attributed with widely acclaimed therapeutic potential for which validated methods for quantitative determination are limited. Objective:: The primary objective was to develop and validate a Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method for simultaneous quantification of total withanolide glycosides (WG), withanoside IV and withaferin A present in ashwagandha extract.The study also aimed to identify various other constituents present in the extract. Materials and Methods: Aqueous methanol extract (AME) of Ashwagandha was prepared and fractionated into two viz. flavonoid rich fraction (FF) and withanolide rich fraction (WF). RP-HPLC method was developed and validated for the estimation of total WG in ashwagandha extract according to ICH guidelines. Preparative HPLC based purification of major compounds from WF fraction was carried out and constituents were identified using spectroscopic techniques. HPLC chemical profiling of WF before and after acid hydrolysis under controlled conditions was carried out to further confirm the glycosidic compounds. Results and Discussion: The RP-HPLC method gave a precise differentiation of flavonoids, withanolides and WG present in ashwagandha extract. The method demonstrated good reliability and sensitivity, and can be conveniently used for the quantification of total WG, withanoside IV and withaferin A present in ashwagandha extracts. According to this method, a purified fraction (WF) prepared from roots and leaves of Ashwagandha comprise 35% of total WG, 3.27% of withanoside IV and 2.40% of Withaferin A. The method was also applied to different products prepared from Ashwagandha with total withanolide glycosides ranged from 1.5% to 60%, and the results were found to be reproducible. Identification of the individual chemical constituents as well as the acid hydrolytic pattern of the extract further supported the reliability of the developed method for the quantitative determination of total WG. This study also reported a new withanolide glycoside named, cilistol V-6’-O-glucoside (Aswanoside) along with some other known withanolide glycosides. Conclusion:: A Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of total WG, withanoside IV and withaferin A present in ashwagandha extract according to ICH guidelines. This study also reported a new withanolide glycoside named, cilistol V-6’-O-glucoside (Aswanoside) along with some other known WG.

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