DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING SIMULTANEOUS ESTIMATION OF METFORMIN AND ALOGLIPTIN IN TABLETS BY HIGH-PERFORMANCE THIN LAYER CHROMATOGRAPHY

MALATHI SELLAPPAN; ARUNADEVI NATARAJAN

doi:10.22159/ijpps.2020v12i12.33871

Authors

MALATHI SELLAPPAN Department of Pharmaceutical Analysis, PSG College of Pharmacy, Peelamedu, Coimbatore, Tamilnadu, 641004, India
ARUNADEVI NATARAJAN Department of Pharmaceutical Analysis, PSG College of Pharmacy, Peelamedu, Coimbatore, Tamilnadu, 641004, India

DOI:

https://doi.org/10.22159/ijpps.2020v12i12.33871

Keywords:

Type 2 diabetes mellitus, Metformin, Alogliptin, High-performance thin-layer chromatography, Stability indicating, Method validation

Abstract

Objective: A simple and stability-indicating high-performance thin-layer chromatographic method was developed and validated for the simultaneous estimation of metformin and alogliptin in tablets.

Methods: The method was developed in TLC aluminum plates pre-coated with silica gel 60F₂₅₄as the stationary phase and the solvent system consists of methanol: chloroform: 0.5% ammonium sulphate [4:4:2, v/v/v]. The system was found to conferred a compact spot for metformin [Rf value of 0.44±0.02] and alogliptin [Rf value of 0.66 ± 0.22]. Densitometric analysis of metformin and alogliptin was carried out at the wavelength of 254 nm. Forced degradation studies were conducted to know the stability of the drug samples under various stress conditions like acid, base, peroxide, photolytic degradation according to the ICH guidelines.

Results: The developed method was found to be suitable for the excellent separation of the drug samples. Calibration curves were linear in the range of 40-200 ng/spot with a correlation coefficient of 0.996 for metformin and calibration curves were linear in the range of 1-5 ng/spot with a correlation co-efficient of 0.997 for alogliptin, respectively. Stability study shows that the chromatograms of samples degraded with acid, base, hydrogen peroxide, dry heat, and photolytic showed well-separated spots of pure metformin and alogliptin as well as some additional peaks at different Rf values. The method was successively applied to pharmaceutical formulation. No chromatographic interference from the tablet excipients was found.

Conclusion: The newly developed method can be applied for the identification and quantitative determination of metformin and alogliptin in the combined dosage form.

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References

Indian Pharmacopoeia. The government of India, Ministry of Health and Family Welfare. Indian Pharmacopoeia Commission Ghaziabad 2005;2-3:1657-186.

Uche AN, Okoli O, Erowele G. Alogliptin: a new dipeptidyl peptidase-4 inhibitor for the management of type 2 diabetes mellitus. Am J Health Syst Pharm 2014;71:103-9.

Dyade GK, Joshi HA, Patil RN. Estimation of metformin hydrochloride and Glimepiride in tablet formulations by UV-visible spectrophotometry. Indo Am J Pharm Res 2013;3:1381-6.

Laxmigoswami, Mukhopadhyay, Durgapal S. Simultaneous estimation of metformin and pioglitazone by ultraviolet spectrophotometry. Indian J Pharm Sci 2010;72:507-10.

Amruta B, Loni R, Minal SD, Ghante, Sawant. Simultaneous UV spectrophotometric method for estimation of sitagliptin phosphate and metformin hydrochloride in bulk and tablet dosage form. Der Pharm Chem 2012;4:854-9.

Neelima K, Rajendra Prasad Y. Analytical method development and validation of metformin, voglibose, glimepiride in bulk, and combined tablet dosage form by gradient RP-HPLC. Pharm Methods 2014;5:27-33.

Amini H, Ahmadiani A, Gazerani P. Determination of metformin in human plasma by high-performance liquid chromatography. J Chromatogr B: Anal Technol Biomed Life Sci 2005;824:319-22.

Madhusudhan P, Radhakrishna Reddy M, Devanna N. A RP-HPLC method development and validation for simultaneous estimation of metformin and rosiglitazone in bulk and tablet dosage form. Der Pharm Lett 2015;7:180-7.

Sunil Dhaneshwar R, Janaki Salunkhe V, Vidhya Bhusar K. Validated HPTLC method for simultaneous estimation of metformin hydrochloride, atorvastatin and glimepiride in bulk drug and formulation. J Anal Bio Anal Techniques 2010;1:1-5.

Darshana K Modi, Punit Parejiya B, Bhavesh H Patel. A simple and sensitive HPTLC method for the simultaneous determination of metformin hydrochloride and sitagliptin phosphate in the tablet dosage form. J Chem 2013;1-4. https://doi.org/10.1155/2013/139561

Jillalasrivani, Balekari Uma Mahesh, Ciddi Veer Sham. Development and validation of stability-indicating HPTLC method for simultaneous determination of linagliptin and metformin. Int J Pharm Pharm Sci 2015;8:112-5.

Supriya P, Madhavi Latha N, Rohith KBV, Ramana GV, Harini U, Pawar AKM. Development and validation of UV spectrophotometric and reversed-phase high-performance liquid chromatography-PDA methods for the estimation of alogliptin benzoate. Asian J Pharm Clin Res 2016;9:282-7.

Sunil Kumar AVVNK, Reddy TV, Sekharan CB. Utility of picric acid and 2,4 dinitrophenol as chromogenic reagents for visible spectrophotometric quantification of alogliptin. Bull Fac Pharm 2017;55:177-84.

Srinivasa Rao G, Mallesh K, Vijay Kumar G, Surekha Ch, Venugopala Rao B. A validated chiral HPLC method for the enantiomeric purity of alogliptin benzoate. Der Pharma Chemica 2014;6:234-9.

Shyam Sundar P, Ishrath Tabassum, Vasanthi R, Alagar Raja M, Rao KNV, Rajeswar Dutt K. Development and validation of stability indicating RP-HPLC method for the simultaneous Estimation of Alogliptin and metformin in bulk and pharmaceutical dosage form. IAJPS 2017;3:223-33.

Anwar Rafique Shaikh, Bakhshi Abdul Rahman Khalil Ahmed, Mohammad Ibrahim A. Validated stability-indicating RP-HPLC method for simultaneous estimation of metformin and teneligliptin in bulk and pharmaceutical dosage form. Int J Pharm Sci Res 2018;4:1705-12.

Komal Sharma, Amrita Parle. Development and validation of the HPTLC method for simultaneous estimation of alogliptin benzoate and pioglitazone hydrochloride in bulk drugs and combined dosage forms. IJPRR 2015;4:35-42.

Hemavathi G, Hipparagi SM. Sensitive LC-MS/MS method for the simultaneous determination of alogliptin and voglibose in human plasma. J Anal Bio Anal Tech 2017;8:1-9.

International conference on harmonization, Impurities in New Drug products Q3B [R2]: ICH harmonized tripartite guidelines; 2006.