Stability Indicating Rp-HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Metformin in Pharmaceutical Dosage Form

Jayaprakash, Ramesh; Natesan, Senthil Kumar

doi:10.22159/ijpps.2017v9i3.16233

Cited by 13 publications

(5 citation statements)

References 6 publications

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“…Forced degradation study was carried to give information about the degradation behavior of analyte in the presence of its degradation products during stress conditions. The API was subjected to hydrolysis (acid and alkali), oxidative, thermal and photolytic stress conditions [20,21]. To assess the stress testing for acid hydrolysis, alkali hydrolysis, and oxidative studies by taking each 5 ml of primary stock solution (200 µg/ml) was transferred into three 50 ml volumetric flasks.…”

Section: Specificity and Forced Degradation Studiesmentioning

confidence: 99%

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Quantification of Ropinirole Hydrochloride in Api and Tablets by Novel Stability-Indicating Rp-HPLC Method: It’s Validation and Forced Degradation Studies

Sadashivaiah¹,

Rohith²,

Babu³

2019

Int J App Pharm

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Objective: A simple, economical, robust and stability-indicating reverse phase high performance liquid chromatography method was developed and validated for the quantification of ropinirole hydrochloride in API and tablets to achieve shorter retention time, to minimize human error by avoiding the use of buffers and weighing procedure and analyze more number of samples in shorter period of time with good accuracy. Methods: The chromatographic conditions for separation of ropinirole hydrochloride was carried out using Gemini NX C18 column (15 cm x 4.6 mm), 5 µm particle size with the mobile phase composing of methanol: acetonitrile (70:30 v/v), delivered at flow rate 0.7 ml/min and UV detection wavelength at 250 nm. Results: The retention time was observed at 2.718 min. The system suitability results were found to be within limits. The method was precise, with lower than 2 %RSD and the calibration curve was linear (r2=1) over a concentration range of 2.5-160 µg/ml. The detection and quantification limit was found to be 0.045 µg/ml and 0.15 µg/ml, respectively. Recovery of the drug was found between 100.09-100.19%. The assay of ropinirole hydrochloride in ROPITOR® and ROPARK® tablets were found to be 100.4 and 103.60 %, respectively. The forced degradation studies were carried out to demonstrate the specificity of the method by exposing the API under conditions of hydrolysis, oxidation, thermal and photolytic as per ICH Q1A(R2) guidelines. Conclusion: The low coefficient of variation and agreeable recovery confirmed that the newly developed method could be employed for routine analysis of ropinirole hydrochloride in API and tablets.

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Section: Specificity and Forced Degradation Studiesmentioning

confidence: 99%

“…The guidelines explicitly require the conduct of forced degradation studies under a variety of conditions like hydrolysis (acid and alkaline), oxidation, photolytic and thermal, etc. and separation of drug from degradation products [20,21].…”

Section: Introductionmentioning

confidence: 99%

Quantification of Ropinirole Hydrochloride in Api and Tablets by Novel Stability-Indicating Rp-HPLC Method: It’s Validation and Forced Degradation Studies

Sadashivaiah¹,

Rohith²,

Babu³

2019

Int J App Pharm

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“…Chromatography was performed on Waters HPLC 2996 system with Empower-2 Software, equipped with a photodiode array detector (PDA) detector and chromatographic separation was performed using BDS column (250 × 4.6 mm, 5 µ) [16].…”

Section: Instrumentationmentioning

confidence: 99%

Development and Validation of Dapagliflozin by Reversed-Phase High-Performance Liquid Chromatography Method and It’s Forced Degradation Studies

Shakirbasha¹,

P²

2017

Asian J Pharm Clin Res

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Objective: To develop and validate a simple, selective, precise, and accurate method for the estimation of dapagliflozin using reversed-phase highperformance liquid chromatography (RP-HPLC) technique in bulk and tablet formulation. Methods:The proposed method utilizes chromatographic conditions hypersil BDS (250 mm × 4.6 mm, 5 µ), mobile phase was buffer:acetonitrile (60:40) ratio, flow rate was maintained 1 ml/minute, column temperature was set at 30°C, detection wave length was 245 nm, and diluent was mobile phase.Results: By injecting 5 times of the standard solution system suitability parameters were studied, and results were found well under the acceptance criteria. The linearity study was performed by taking 25-150% levels, and the R 2 value was found to be 0.999, precision was found to be 0.5 for repeatability and 0.31 for intermediate precision. The % recovery was found to be 99.89%. Limit of detection and limit of quantitation were found to be 0.60 µg/ml and 1.81 µg/ml, respectively. The % purity was found to be 99.71%. Degradation study on dapagliflozin was performed and concluded that the purity threshold was more than purity angle and within the acceptable range. Conclusion:The developed RP-HPLC method for dapagliflozin was found to be simple, precise, accurate, reproducible, and cost effective. Statistical analysis of the developed method conforms that the proposed method is an appropriate and it can be useful for the routine analysis. This method gives the basic idea to the researcher who is working in area such as product development and finish product testing.

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“…It is based on using the higher derivative of absorbance with the wavelength of parent zero-order spectra. A detailed review of the literature was studied for vildagliptin in single and combination forms such as spectrophotometric (Vaishali et al, 2021;Samer et al, 2019), HPLC (Abu et al, 2018;Jayaprakash and Natesan, 2017), LC/MS/MS (Sakthimanigandan et al, 2015) GC-MS (Uçaktürk, 2015) Capillary electrophoresis (Mahesh et al, 2017) and HPTLC (Patil et al, 2020). Derivative spectroscopy is an economi-cal method with minimal reagents and development period when compared with other analytical techniques.…”

Section: Introductionmentioning

confidence: 99%

A New Second-Derivative Spectrophotometric Method for the Determination of Vildagliptin in Pharmaceutical dosage form

Subhadip

et al. 2021

ijrps

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An accurate derivative spectrophotometric method was developed and validated for the determination of dipeptidyl peptidase inhibitor vildagliptin in the pharmaceutical dosage form. The second derivative of the UV spectra has enabled the estimation of vildagliptin absorbance at 217 nm without any interferences. Linearity, precision, accuracy, detection (LOD), and quantification (LOQ) limits were established for method validation. Calibration curve was linear in the range of 10-60 µg/mL with a regression coefficient of 0.998. The method was validated as per the International Conference on Harmonization (ICH Q2 (R1)). The limit of detection and the limit of quantification were found to be 2.06 µg/mL and 6.25 µg/mL, respectively. Intra and interday precision data illustrated that the method has acceptable reproducibility as the percentage relative standard deviation (RSD) was less than 2 %, which indicates the precision of the method. The recovery was 98.39 % by the standard addition method. The percentage assay of vildagliptin was 98.06 % which showed good applicability. The following results indicate that the procedure is accurate, precise, and reproducible while being simple and less time-consuming. The method was demonstrated to be adequate for routine analysis in quality control.

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Stability Indicating Rp-HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Metformin in Pharmaceutical Dosage Form

Cited by 13 publications

References 6 publications

Quantification of Ropinirole Hydrochloride in Api and Tablets by Novel Stability-Indicating Rp-HPLC Method: It’s Validation and Forced Degradation Studies

Quantification of Ropinirole Hydrochloride in Api and Tablets by Novel Stability-Indicating Rp-HPLC Method: It’s Validation and Forced Degradation Studies

Development and Validation of Dapagliflozin by Reversed-Phase High-Performance Liquid Chromatography Method and It’s Forced Degradation Studies

A New Second-Derivative Spectrophotometric Method for the Determination of Vildagliptin in Pharmaceutical dosage form

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