A New Stability Indicating Rp-Hplc Method For Simultaneous Estimation Of Ertugliflozin And Sitagliptin In Bulk And Pharmaceutical Dosage Form Its Validation As Per Ich Guidelines

Rao, P. Venkateswara; Rao, A. Lakshmana; Prasad, S. V. U. M.

doi:10.5281/zenodo.1220228

2018

DOI: 10.5281/zenodo.1220228

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A New Stability Indicating Rp-Hplc Method For Simultaneous Estimation Of Ertugliflozin And Sitagliptin In Bulk And Pharmaceutical Dosage Form Its Validation As Per Ich Guidelines

P. Venkateswara Rao¹,

A. Lakshmana Rao²,

S. V. U. M. Prasad³

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Novel stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations

Addanki

2021

Futur J Pharm Sci

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Background The present investigation was proposed to develop a simple, sensitive, rapid, accurate, precise stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin. Chromatographic separation was performed with Waters Hibar C8 [100×2.1mm, 2μ] column and mobile phase acetonitrile: water (pH 3.5) [50:50%, v/v], pumped at a flow rate 0.2ml/min. The separated analytes were detected with a UV detector at a wavelength of 218nm. Results The separation of sitagliptin and ertugliflozin was done at a retention time of 0.859min and 1.570min, respectively. The present method was validated according to the ICH guidelines Q2 R1, and stability-indicating studies were carried out as per ICH guidelines Q1A R2. Intra-day and inter-day precision were found to be within acceptable limits. The linearity of the proposed method was in the concentration range of 25–125μg/ml and 3.75–22.5μg/ml for sitagliptin and ertugliflozin, respectively. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.5μg/ml and 1.53μg/ml for sitagliptin and 0.13μg/ml and 0.38μg/ml for ertugliflozin, respectively. The recovery of the method was found in between 99.7% and 100.7%. Conclusion The proposed method was able to distinguish the analytes from by-products. Hence, the method was successfully implied for stability-indicating studies and for routine examination of sitagliptin and ertugliflozin in pharmaceutical formulation.

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Novel stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations

Addanki

2021

Futur J Pharm Sci

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Stability Indicating UPLC Method Development and Validation for Simultaneous Determination of Ertugliflozin and Sitagliptin

Goud¹,

Prasanna²,

Shymala³

et al. 2019

AJPTR

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A selective, robust, economic and short method was developed for the simultaneous estimation of the Ertugliflozin (EGZ) and Sitagliptin (SGP) in Tablet dosage form. Chromatogram was run through X-bridge c18 50 x 2.1 mm, 1.7. Mobile phase containing Buffer: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.01N KH2PO4(3.0PH)buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 240 nm Retention time of EGZ and SGP were found to be 0.883 min and 1.465 min.%RSD of the EGZ and SGP were and found to be 0.3 and 0.8 respectively. %Recovery was obtained as 99.83% and 100.09% for EGZ and SGP respectively. LOD, LOQ values obtained from regression equations of EGZ and SGP were 0.139, 0.421 and 0.18, 0.56 respectively. Regression equation of EGZ is y = 4300x + 253.6, and y = 6814x + 11844 of SGP. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries

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A New Stability Indicating Rp-Hplc Method For Simultaneous Estimation Of Ertugliflozin And Sitagliptin In Bulk And Pharmaceutical Dosage Form Its Validation As Per Ich Guidelines

Cited by 2 publications

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Novel stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations

Novel stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations

Stability Indicating UPLC Method Development and Validation for Simultaneous Determination of Ertugliflozin and Sitagliptin

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