RP-HPLC Method for the Simultaneous Estimation of Sitagliptin Phosphate and Metformin Hydrochloride in Combined Ttablet Dosage Forms

Bhende, Swati D.; Varanasi, Murali Balaram; Abbulu, K; M, Swetha; Shravanthi, V.; Kumari, Jyoti; Shayamala, T.

doi:10.13005/ojc/280158

Cited by 8 publications

(2 citation statements)

References 2 publications

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“…In addition, the method was found to be free from cumbersome mobile phase composition with additional advantages of less consumption of organic solvents that of reported methods of Konari and Jane 5 , Shyamala et al 16 , Bhende et al 17 , Rao et al 18 and Patil et al 21 …”

Section: Parametersmentioning

confidence: 90%

“…Most of the reported methods for the estimation of sitagliptin contained complex mixture in mobile phase 5,16 , higher percentages of organic solvent in mobile phase 15,19,20 and relatively long retention time. 17,18,22 Therefore, we aimed to establish a validated cost-effective, simple, fast and precise UHPLC method to determine sitagliptin in oral tablet dosage form. Instrumentation.…”

Section: Sitagliptin Chemically [(R)mentioning

confidence: 99%

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Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

Sultana

Hossain

Islam

et al. 2018

Dhaka Univ. J. Pharm. Sci

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ABSTRACT:A novel reversed phase ultra-high performance liquid chromatographic (RP-UHPLC) method was developed for the estimation of sitagliptin in pharmaceutical dosage form. Separation was done by a X-bridge C18 column (4.6 i.d.× 150 mm, 5 μm particle size) with a flow rate of 1 ml/min using phosphate buffer (pH 6) and acetonitrile (70:30, v/v) as mobile phase at 268 nm using photodiode array plus (PDA+) detector. The retention time was found at 4.607 min. The developed method was validated as per the requirements of ICH-Q2B guidelines for specificity, system suitability, linearity, precision, accuracy, sensitivity and robustness. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.999 with LOD value of 0.06 µg/ml and LOQ of 0.225 µg/ml. The relative standard deviation (%RSD) for inter-day and intra-day precision was not more than 2.0%. The method was found to be accurate with percentages recovery of 98.50±0.03 to 99.70±0.05 and the % RSD was less than 2. The results showed that the proposed method is highly convenient for routine analysis of sitagliptin.

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Section: Parametersmentioning

confidence: 90%

Section: Sitagliptin Chemically [(R)mentioning

confidence: 99%

Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

Sultana

Hossain

Islam

et al. 2018

Dhaka Univ. J. Pharm. Sci

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Quadruple Response Factorial Design Optimization of Capillary Zone Electrophoresis Assay Procedure for Metformin and Sitagliptin Combination

Alnajjar

Idris

Attimarad

et al. 2015

Journal of Liquid Chromatography & Related Technologies

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DoE-Based Analytical Failure Modes Critical Effect Analysis (AFMCEA) to a Multipurpose-RP-HPLC Method for the Estimation of Multiple FDC Products of Metformin Hydrochloride Using an Analytical Quality by Design Approach

Prajapati

Shahi

Shah

2022

Journal of AOAC INTERNATIONAL

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Background Metformin hydrochloride is the first choice antihyperglycemic agent and its several fixed-dose combinations (FDCs) with pioglitazone hydrochloride, sitagliptin phosphate and gliclazide are used for the management of type II diabetes. Numerous RP-HPLC and HPTLC methods have been reported for estimation of FDCs of metformin but each FDC needs separate and dedicated chromatographic conditions for analysis. No RP-HPLC method has been reported yet which promotes synchronous estimation of FDC products of metformin to save time, resources, cost and organic solvent for analysis. Objective Hence, an economical and eco-friendly RP-HPLC method was developed for the synchronous estimation of FDCs of metformin hydrochloride using an enhanced AQbD approach. Methods The AQbD approach was implemented using analytical-FMCEA as per ICH Q8 and Q9 guidelines. The analytical-FMCEA was applied by identification of potential analytical failure modes followed by their risk assessment by RPN ranking and filtering method. Further, the risk of critical failure modes was controlled and mitigated by a DoE-based Box-Behnken design by navigation of MODR. Results From the set of control strategies, the RP-HPLC method was developed using Shim-Pack ODS C18 column and acetonitrile-0.1%v/v triethylamine in water (pH 3.2 adjusted by perchloric acid). The method was found to be validated as per ICH Q2 (R1) guideline. The synchronous estimation of different FDCs of metformin hydrochloride was carried out by the developed method. Conclusion The developed method can be used as a multipurpose-chromatography method as an alternative to published chromatography methods for quality control of FDCs of metformin hydrochloride in the pharmaceutical industry. Highlights The multipurpose RP-HPLC method has been developed and validated for the synchronous estimation of multiple combined pharmaceutical dosage forms of metformin hydrochloride. The method was developed by the implementation of the AFMCEA-based AQbD approach as per the regulatory requirements of ICH.

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RP-HPLC Method for the Simultaneous Estimation of Sitagliptin Phosphate and Metformin Hydrochloride in Combined Ttablet Dosage Forms

Cited by 8 publications

References 2 publications

Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique

Quadruple Response Factorial Design Optimization of Capillary Zone Electrophoresis Assay Procedure for Metformin and Sitagliptin Combination

DoE-Based Analytical Failure Modes Critical Effect Analysis (AFMCEA) to a Multipurpose-RP-HPLC Method for the Estimation of Multiple FDC Products of Metformin Hydrochloride Using an Analytical Quality by Design Approach

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