RP-HPLC determination of vildagliptin in pure and in tablet formulation

Thangabalan, B.; Kumar, Palanirajan Vijayaraj

doi:10.1016/j.jopr.2013.01.001

Cited by 19 publications

(13 citation statements)

References 7 publications

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“…Various methods such as liquid chromatography (LC) [4], LC-electrospray ionization tandem mass spectrometry [5], high-performance LC (HPLC) [6,7], capillary HPLC [8], and electrokinetic capillary HPLC [8] had been reported for the determination of azelastine and its metabolite in biofluids. Visible spectrophotometric method [9], HP thin-layer chromatography (HPTLC) [10], reversed-phase HPLC (RP-HPLC) [11], and Fourier transform infrared [12] have been developed for estimation of AZL in formulation. RP-HPLC [13] method has been reported for simultaneous estimation of AZL and fluticasone propionate in formulation.…”

Section: Introductionmentioning

confidence: 99%

Stability-Indicating High-Performance Liquid Chromatography Method for Determination of Antihistamine Drug Azelastine

Patel

Pasha

2018

Asian J Pharm Clin Res

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Objective: The objective of this research was to develop a simple, precise, accurate, and stability-indicating reverse-phase high-performance liquid chromatographic method for estimation of azelastine hydrochloride (AZL) in nasal spray preparation. Methods:Chromatography was performed on a 250 mm×4.6 mm, 5-μm particle size, Waters Spherisorb CN column using (50:50 v/v) mixture of potassium dihydrogen phosphate buffer and acetonitrile as mobile phase. The detection was carried out at 290 nm and flow rate employed was 1.0 ml/min. The degradation of AZL was studied under different ICH recommended stress conditions. Results:The retention time was 4.34 min for AZL. Linearity was established in the concentration range of 5-120 µg/ml, with a correlation coefficient of 0.9996. Limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.81 µg/ml and 2.44 µg/ml, respectively. Percentage recovery was found between 99 and 102%. The values of percentage relative standard deviation (<2%) proved the high precision of the proposed method. The method was found to be robust regarding any small variation in the column temperature, pH of mobile phase, and mobile phase ratio. AZL was found stable in 5 M HCl at 80°C for 5 h, 5 M NaOH at 80°C for 5 h, 30% H 2 O 2 at 80°C for 5 h, and in oven at 70°C for 8 h. Conclusion:The results obtained in this research work clearly proved that the proposed HPLC method for the assay of AZL in nasal spray preparation is simple, precise, specific, accurate, and stability indicating. It indicates that the method is suitable for analysis of AZL in the raw material and the pharmaceutical product without interference from excipients.

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Section: Introductionmentioning

confidence: 99%

Stability-Indicating High-Performance Liquid Chromatography Method for Determination of Antihistamine Drug Azelastine

Patel

Pasha

2018

Asian J Pharm Clin Res

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“…Moreover, our method is one of the most sensitive reported for the determination of AZL, permitting determination of the drug at the ng level and facilitating its quantitation in metered dose nasal sprays. The proposed method has been found to be ~20–50 times more sensitive than the previously reported method ; in addition, the proposed method does not require complicated set‐up, unlike another method reported in the literature that needs a sophisticated LC–MS instrument .…”

Section: Introductionmentioning

confidence: 82%

“…A review of the literature revealed several analytical methods for the determination of AZL in either its pure or dosage forms, including spectrophotometry (3)(4)(5), electrochemical methods (6,7), thin-layer chromatography (TLC) (8) highperformance liquid chromatography (HPLC) (9)(10)(11)(12) and liquid chromatography-tandem mass spectrometry (LC/MS/MS) (13,14). However, all these methods use expensive instruments and tedious procedures.…”

Section: Introductionmentioning

confidence: 99%

Validated sensitive spectrofluorimetric method for determination of antihistaminic drug azelastine HCl in pure form and in pharmaceutical dosage forms: application to stability study

et al. 2016

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A highly sensitive, simple and rapid spectrofluorimetric method was developed for the determination of azelastine HCl (AZL) in either its pure state or pharmaceutical dosage form. The proposed method was based on measuring the native fluorescence of the studied drug in 0.2 M H SO at λ = 364 nm after excitation at λ = 275 nm. Different experimental parameters were studied and optimized carefully to obtain the highest fluorescence intensity. The proposed method showed a linear dependence of the fluorescence intensity on drug concentration over a concentration range of 10-250 ng/mL, with a limit of detection of 1.52 ng/mL and limit of quantitation of 4.61 ng/mL. Moreover, the method was successfully applied to pharmaceutical preparations, with percent recovery values (± SD) of 99.96 (± 0.4) and 100.1 (± 0.52) for nasal spray and eye drops, respectively. The results were in good agreement with those obtained by the comparison method, as revealed by Student's t-test and the variance ratio F-test. The method was extended to study the stability of AZL under stress conditions, where the drug was exposed to neutral, acidic, alkaline, oxidative and photolytic degradation according to International Conference on Harmonization (ICH) guidelines. Copyright © 2016 John Wiley & Sons, Ltd.

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“…Several analytical methods have been reported for the determination of Pramipexole, either in pharmaceutical preparations or in biological fluids [27][28][29][30]. The references cited here have exhaustively enumerated the earlier analytical methods on this drug.…”

Section: Pramipexole Hcl (Pam)mentioning

confidence: 99%

Quantitative Determination of drugs & pharnaceuticalsby using iodine as analytical reagent: A spectrophotometric study

Kumar¹,

Seethamma²,

Venkateshwarlu³

2014

IOSRJAC

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RP-HPLC determination of vildagliptin in pure and in tablet formulation

Cited by 19 publications

References 7 publications

Stability-Indicating High-Performance Liquid Chromatography Method for Determination of Antihistamine Drug Azelastine

Stability-Indicating High-Performance Liquid Chromatography Method for Determination of Antihistamine Drug Azelastine

Validated sensitive spectrofluorimetric method for determination of antihistaminic drug azelastine HCl in pure form and in pharmaceutical dosage forms: application to stability study

Quantitative Determination of drugs & pharnaceuticalsby using iodine as analytical reagent: A spectrophotometric study

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