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

Subhadip, C; R, Nalanda Baby; G, Pridhvi Krishna; M, Suraj; T, Shyamdeo Kumar

doi:10.26452/ijrps.v12i4.4914

Cited by 3 publications

(3 citation statements)

References 6 publications

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“…The designed and validated approach was linear, accurate, precise, and robust against the wide concentration of ritonavir, which might help qualitative and quantitative validation. The significant objective of this study was to pinpoint the spectroscopic and chromatographic techniques that were reliable enough to produce an appropriate separation of the components with a good spectrum for the UV-spectroscopic method and chromatogram within a reasonable run time for the high-performance liquid chromatographic method [29][30][31]. The target analytical profile was created to identify critical method attributes influencing critical quality attributes, and a systematic risk analysis was conducted.…”

Section: Discussionmentioning

confidence: 99%

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

PARVEEN,

ROUTH,

GOSWAMI

et al. 2023

Int J App Pharm

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Objective: To specify ritonavir and its commercial dosage form, the current study set out to design and validate concise, precise, and efficient high-performance liquid chromatography and spectrophotometric methods. The developed spectroscopy and chromatographic methods are reliable, precise, accurate, and specific for estimating ritonavir. Methods: The method is superior to previously described methods due to its shorter retention duration, use of an affordable and easily accessible mobile phase, UV detection, and improved peak resolution. The maximum absorbance was determined by analysing multiple concentration ranges of ritonavir at 10-60 µg/ml using the UV-spectrophotometric method. The chromatographic separation was performed with a mobile phase composed of acetonitrile and 0.1% formic acid (1:1 v/v) pumped at a 1.0 ml/min flow rate on a phenyl (150 x 4.6 mm, 3.5 µm) column. Results: Obeyed Beer-Lambert law over the 10-60 µg/ml and 25-150 µg/ml concentration range of ritonavir for the UV-spectrophotometric and HPLC methods, respectively. The absorbance at 273 nm was selected as the maximum absorbance throughout the UV-spectroscopic study. The detection and quantification limits for UV-spectroscopic are 0.89 and 2.93 µg/ml, whereas for the HPLC method are 0.78 and 2.57 µg/ml, respectively. In the accuracy and precision validation studies, the amount of recovery and percentage of RSD was excellent with acceptance limits as per International Conference on Harmonization (ICH) guidelines. Conclusion: The suggested method has been approved following standards established by the ICH. The developed methods can be employed to analyse ritonavir API and pharmaceutical dosage forms and provide better specificity, excellent separation, and specified analyte and degradation substances.

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Section: Discussionmentioning

confidence: 99%

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

PARVEEN,

ROUTH,

GOSWAMI

et al. 2023

Int J App Pharm

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“…Developed primary data may be used by recovering unresolved band spectra 21 . A blank solution was preserved for the diluent.…”

Section: Methods C (Second-order Spectrophotometric Method)mentioning

confidence: 99%

A Stability Indicating Method was Developed and Validation for the Estimation of Carbamazepine in Bulk and Tablet Dosage form by UV-Spectroscopic Techniques

Ghosh

Mondal

Chakraborty

et al. 2023

J. Drug Delivery Ther.

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Carbamazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and nerve pain, such as trigeminal neuralgia and diabetic neuropathy. It is well known that contemporary pharmaceutical analysis establishes robust, sensitive, economic, stability-indicating analytical procedures. The current study aimed to develop and assess UV-spectrophotometric (zero order, first order, second order, area under the curve) methods for estimating carbamazepine in its pharmaceutical dosage form. Method A is a simple zero-order spectrophotometric method for determining carbamazepine at 285 nm, and the correlation coefficient in the linearity study was found to be 0.9976, LOD, and LOQ are 0.45 and 1.48 µg/ml. Method B is a first-order spectrophotometric method for determining carbamazepine at 269 nm, and the correlation coefficient in the linearity study was found to be 0.9944, LOD, and LOQ are 0.29 and 0.96 µg/ml. Method C is a second-order spectrophotometric method for determining carbamazepine at 254 nm, and the correlation coefficient in the linearity study was found to be 1.00, LOD, and LOQ are 0.62 and 2.04 µg/ml. Method D is an area under the curve spectrophotometric method for determining carbamazepine at 266 to 300 nm, and the correlation coefficient in the linearity study was found to be 0.9975, LOD, and LOQ are 0.14 and 0.46 µg/ml. All developed methods demonstrated good repeatability and recovery with %RSD < 2. Studies on stress degradation show that oxidation and acid degradation mostly impact carbamazepine solutions. Keywords: Carbamazepine, UV-spectrophotometric, Tegrital, Degradation study.

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“…Developed primary data may be used by recovering unresolved band spectra [22]. A blank solution was preserved for the diluent.…”

Section: Methods C (Second-order Spectrophotometric Method)mentioning

confidence: 99%

A Promising Analytical Method has been Crafted, Validated, and Quantified for Estimating Theophylline Utilizing UV Spectroscopic and RP-HPLC Techniques in Conjunction with Stress Degradation Studies to Pinpoint Deterioration

Madhavi

Mondal

Chakraborty

et al. 2023

J. Pharm. Res. Int.

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Introduction: The current study aimed to develop and assess UV-spectrophotometric (zero order, first order, second order, area under the curve) and RP-HPLC methods for estimating theophylline in its pharmaceutical dosage form. Methods: A less toxic solvent composition of acetonitrile and 0.1% orthophosphoric acid (25:75 v/v) is used as a mobile phase and diluent for developing both UV-spectroscopic and RP-HPLC techniques. Shimadzu Prominence LC-20A Modular HPLC system with a C18 column (250 × 4.6 mm; 5 µm) was used to develop the RP-HPLC method. Results: Method A is a zero-order spectrophotometric method for determining theophylline at 271 nm, and the correlation coefficient in the linearity study was found to be 0.9958, LOD, and LOQ are 0.52 and 1.71 µg/mL. Method B is a first-order spectrophotometric method for determining theophylline at 258 nm, and the correlation coefficient in the linearity study was found to be 0.9983, LOD, and LOQ are 0.46 and 1.51 µg/mL. Method C is a second-order spectrophotometric method for determining theophylline at 218 nm, and the correlation coefficient in the linearity study was found to be 0.9941, LOD, and LOQ are 0.38 and 1.25 µg/mL. Method D is an area under the curve spectrophotometric method for determining theophylline at 260 to 282 nm, and the correlation coefficient in the linearity study was found to be 0.9978, LOD, and LOQ are 0.57 and 1.88 µg/mL. Method E is the RP-HPLC method for the determination of theophylline at the retention time of 2.814 min, and the correlation coefficient in the linearity study was found to be 0.9923, LOD, and LOQ are 0.78 and 2.57 µg/mL. Studies on stress degradation show that oxidation and acid degradation mostly impact theophylline solutions. Conclusion: Theophylline can be determined using the proposed approach, which is convenient, precise, affordable, and reproducible.

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

Cited by 3 publications

References 6 publications

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

A Stability Indicating Method was Developed and Validation for the Estimation of Carbamazepine in Bulk and Tablet Dosage form by UV-Spectroscopic Techniques

A Promising Analytical Method has been Crafted, Validated, and Quantified for Estimating Theophylline Utilizing UV Spectroscopic and RP-HPLC Techniques in Conjunction with Stress Degradation Studies to Pinpoint Deterioration

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