Remogliflozin etabonate and teneligliptin simultaneous estimation in pharmaceutical dosage form using a stability indicating HPLC - DAD procedure
Öz
The objective of the present effort is developing a fully green-assessed stability-indicating reverse phase liquid chromatography for the assessable measurement regarding Remogliflozin etabonate (RGE) & Teneligliptin (TEN) in drug substance and tablets and fully validated as per ICH criteria. Waters Atlantis T3 (150mm x 4.6, 3.5µm) column, 30 volumes acetonitrile along with 70 volumes ammonium formate (pH-3.0) mobile phase pumped at a flow rate of 1.0ml/min were used for the chromatographic separation using PDA exposure at 236 nm wavelength. Remogliflozin etabonate, Teneligliptin were separated at 2.730, 4.468 minutes of retention times respectively. ICH guidelines Q2 R1 was employed to validate the current procedure. Accuracy measurements were acceptable to intra-day and inter-day measurements. For RGE & TGN, respectively, the recommended technique was linear in the concentration ranges of 25– 150µg/ml and 2.5–15 µg/ml. y=29777x+67797 and y= 30689 x +22270 respectively were the observed regression equations for RGE and TEN. The limits of detection (LOD) and quantification (LOQ) for Remogliflozin etabonate & Teneligliptin were respectively 0.3 (µg/ml), 1 (µg/ml) and 0.03(µg/ml), 0.1(µg/ml). The recovery percentage of the method was found to remain in between 98% and 100%. Q1A R2 and Q1B guidelines were followed for conducting stability-indicating studies. The technique can also be utilized for quality control and repetitive laboratories evaluation aimed at the simultaneous assessment of RGE & TEN in the drug substance and pharmaceutical dosage form.
Anahtar Kelimeler
RP-HPLC Remogliflozin etabonate Teneligliptin Validation Forced degradation studies ICH guidelines
Kaynakça
- [1] Nachiket D, Ganesh S, Jyoti V. Simultaneous estimation, validation and force degradation study of metformin hydrochloride and empagliflozin by RP HPLC method. Res J Sci Tech. 2019; 11(2): 135-147. https://doi.org/10.5958/2349-2988.2019.00021.4.
- [2] Rahul G, Ganesh S, Shraddha J. Simultaneous estimation and validation of dapagliflozin and saxagliptin in bulk drug and dosage form by RP-HPLC. Res J Sci Tech. 2019; 11(1): 59-63. https://doi.org/10.5958/2349-2988.2019.00008.1.
- [3] Santosh J, Sanjay P, Virendra Y, Ashpak T. Zero order and area under curve spectrophotometric methods for determination of atenolol in pharmaceutical formulation. Res J Pharm Dosage Form Tech. 2015; 7(3): 185- 189. https://www.doi.org/10.5958/0975-4377.2015.00027.0.
- [4] Anand C, Murli K. Evaluation and marker quantification of antidiabetic herbal tablets: steve Tab and Andro Tab by HPLC method. Res J Pharm Dosage Form Tech. 2013; 5(1): 17-21.
- [5] Fujimori Y, Katsuno K, Nakashima I, Ishikawa-TY, Fujikura H, Isaji M. Remogliflozin etabonate in a novel category of selective low-affinity sodium glucose cotransporter (SGLT2) inhibitors, exhibits antidiabetic efficacy in rodent models. J Pharmacol Exp Ther. 2008; 327: 268–276. https://doi.org/10.1124/jpet.108.140210.
- [6] Rang, Dale’s Pharmacology, sixth ed., Churchil livingstone Publishers (P) Ltd, New York, 2004; pp. 277-285.
- [7] Drug bank, Teneligliptin. www.drugbank.ca/drugs/DB11950 (accessed on 04 March 2023).
- [8] Attimarad M, Venugopala KN, Nair AB, Sreeharsha N, Deb PK. Experimental design approach for quantitative expressions of simultaneous quantification of two binary formulations containing remogliflozin and gliptins by RP-HPLC. Separations. 2022; 9(2):23. https://doi.org/10.3390/separations9020023
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- [10] Biswas B,J Kumar M, Sharma JB, Saini V, Bhatt S.Method development and validation for estimation of teneligliptin in tablet dosage form by RP-HPLC. Res J Pharm Tech. 2020; 13(4): 1774-1778. http://doi.org/10.5958/0974-360X.2020.00320.0
- [11] Dhanabalan K, Rangasamy M, Gopal SK, Sivalingam A, Jeeva BP, Venkatesh D, Ayyandurai GR , Loganathan H, Vishwanathan D. Method development, validation and forced degradation behaviour of teneligliptin and remogliflozin etabonate in combined dosage form by RP-HPLC method. Eur Chem Bull. 2023; 12(S3): 173-183.
- [12] Eman AB, Hisham H, Hanaa S, Ebraam BK, Maya SE. Stability-indicating HPLC-DAD and TLC-densitometry methods for the quantification of bupivacaine and meloxicam in their co-formulated mixture. Microchem J. 2023; 190: 108683. https://doi.org/10.1016/j.microc.2023.108683
- [13] Michael GF, Ebraam BK. Sustainable Stability-Indicating spectra manipulations for the concurrent quantification of a novel anti-COVID-19 drug and its active metabolite: Green profile assessment. Spectrochim Acta A Mol Biomol Spectrosc. 2023; 300: 122911. https://doi.org/10.1016/j.saa.2023.122911
- [14] Gałuszka A, Migaszewski Z, Namieśnik J. The 12 principles of green analytical chemistry and the SIGNIFICANCE mnemonic of green analytical practices. Trends Anal Chem. 2013; 50: 78-84. http://doi.org/10.1016/j.trac.2013.04.010
- [15] Płotka JW. A new tool for the evaluation of the analytical procedure: Green analytical procedure index. Talanta. 2018; 181: 204-209. https://doi.org/10.1016/j.talanta.2018.01.013
- [16] Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE-Analytical GREEnness Metric Approach and Software. Anal Chem. 2020;92(14):10076-10082. https://doi.org/10.1021/acs.analchem.0c01887
- [17] Lloyd RS, Joseph JK, Joseph LG. Practical HPLC method development and validation. second ed., New York, USA 1979.
Öz
Kaynakça
- [1] Nachiket D, Ganesh S, Jyoti V. Simultaneous estimation, validation and force degradation study of metformin hydrochloride and empagliflozin by RP HPLC method. Res J Sci Tech. 2019; 11(2): 135-147. https://doi.org/10.5958/2349-2988.2019.00021.4.
- [2] Rahul G, Ganesh S, Shraddha J. Simultaneous estimation and validation of dapagliflozin and saxagliptin in bulk drug and dosage form by RP-HPLC. Res J Sci Tech. 2019; 11(1): 59-63. https://doi.org/10.5958/2349-2988.2019.00008.1.
- [3] Santosh J, Sanjay P, Virendra Y, Ashpak T. Zero order and area under curve spectrophotometric methods for determination of atenolol in pharmaceutical formulation. Res J Pharm Dosage Form Tech. 2015; 7(3): 185- 189. https://www.doi.org/10.5958/0975-4377.2015.00027.0.
- [4] Anand C, Murli K. Evaluation and marker quantification of antidiabetic herbal tablets: steve Tab and Andro Tab by HPLC method. Res J Pharm Dosage Form Tech. 2013; 5(1): 17-21.
- [5] Fujimori Y, Katsuno K, Nakashima I, Ishikawa-TY, Fujikura H, Isaji M. Remogliflozin etabonate in a novel category of selective low-affinity sodium glucose cotransporter (SGLT2) inhibitors, exhibits antidiabetic efficacy in rodent models. J Pharmacol Exp Ther. 2008; 327: 268–276. https://doi.org/10.1124/jpet.108.140210.
- [6] Rang, Dale’s Pharmacology, sixth ed., Churchil livingstone Publishers (P) Ltd, New York, 2004; pp. 277-285.
- [7] Drug bank, Teneligliptin. www.drugbank.ca/drugs/DB11950 (accessed on 04 March 2023).
- [8] Attimarad M, Venugopala KN, Nair AB, Sreeharsha N, Deb PK. Experimental design approach for quantitative expressions of simultaneous quantification of two binary formulations containing remogliflozin and gliptins by RP-HPLC. Separations. 2022; 9(2):23. https://doi.org/10.3390/separations9020023
- [ 9] Kanna KL, Panigrahy UP. Stability indicating method development and validation of remogliflozin etabonate in bulk and pharmaceutical dosage form by RP-HPLC. Int J Pharm Sci Res. 2021; 12(8): 4197-4207. https://doi.org/10.13040/IJPSR.0975-8232.12(8).4197-07.
- [10] Biswas B,J Kumar M, Sharma JB, Saini V, Bhatt S.Method development and validation for estimation of teneligliptin in tablet dosage form by RP-HPLC. Res J Pharm Tech. 2020; 13(4): 1774-1778. http://doi.org/10.5958/0974-360X.2020.00320.0
- [11] Dhanabalan K, Rangasamy M, Gopal SK, Sivalingam A, Jeeva BP, Venkatesh D, Ayyandurai GR , Loganathan H, Vishwanathan D. Method development, validation and forced degradation behaviour of teneligliptin and remogliflozin etabonate in combined dosage form by RP-HPLC method. Eur Chem Bull. 2023; 12(S3): 173-183.
- [12] Eman AB, Hisham H, Hanaa S, Ebraam BK, Maya SE. Stability-indicating HPLC-DAD and TLC-densitometry methods for the quantification of bupivacaine and meloxicam in their co-formulated mixture. Microchem J. 2023; 190: 108683. https://doi.org/10.1016/j.microc.2023.108683
- [13] Michael GF, Ebraam BK. Sustainable Stability-Indicating spectra manipulations for the concurrent quantification of a novel anti-COVID-19 drug and its active metabolite: Green profile assessment. Spectrochim Acta A Mol Biomol Spectrosc. 2023; 300: 122911. https://doi.org/10.1016/j.saa.2023.122911
- [14] Gałuszka A, Migaszewski Z, Namieśnik J. The 12 principles of green analytical chemistry and the SIGNIFICANCE mnemonic of green analytical practices. Trends Anal Chem. 2013; 50: 78-84. http://doi.org/10.1016/j.trac.2013.04.010
- [15] Płotka JW. A new tool for the evaluation of the analytical procedure: Green analytical procedure index. Talanta. 2018; 181: 204-209. https://doi.org/10.1016/j.talanta.2018.01.013
- [16] Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE-Analytical GREEnness Metric Approach and Software. Anal Chem. 2020;92(14):10076-10082. https://doi.org/10.1021/acs.analchem.0c01887
- [17] Lloyd RS, Joseph JK, Joseph LG. Practical HPLC method development and validation. second ed., New York, USA 1979.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | İlaç Dağıtım Teknolojileri |
| Bölüm | Articles |
| Yazarlar | |
| Yayımlanma Tarihi | 28 Haziran 2025 |
| Yayımlandığı Sayı | Yıl 2024 Cilt: 28 Sayı: 5 |