DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF GLICLAZIDE AND SITAGLIPTIN PHOSPHATE MONOHYDRATE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Keywords:
Gliclazide, Sitagliptin phosphate monohydrate, Simultaneous estimationAbstract
Objective: The present study describes a simple, accurate, precise, specific and economical UV spectrophotometric method for simultaneous estimation of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) in bulk and pharmaceutical dosage form.
Methods: The method was validated in terms of linearity, sensitivity, accuracy, precision, limit of detection and limit of quantification. The solvent used was methanol and the absorption maxima for Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) were found to be 226 nm and 267 nm respectively.
Results: The percentage recovery of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) were 99.8% and 99.64% respectively. The linear response was observed in the range of 7-27 µg/ml and 20-100 µg/ml with a correlation coefficient (r2) of 0.996 and 0.998 for Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) respectively.
Conclusion: The proposed method was successfully applied for the quantitative detection of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) in Pharmaceutical dosage form.
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Revathi R, Saravanan VS, Mohan Raj P, Ethiraj T, Ganesan V. Spectrophotometric estimation of Gliclazide in bulk and pharmaceutical dosage forms. Int Res J Pharm 2010;1(1):277–81.
Sharma GS, Srikanth MV, Sunil SA, Sreenivasa Rao N, Ramana Murthy KV. Dissolution rate enhancement of poorly soluble gliclazide by complexation with hydroxy propyl β cyclodextrin. Res J Pharm Biol Chem Sci 2011;2(3):814–23.
Pinderjit Singh, Rajnish Kumar, Harinder Singh. Application of UV spectrophotometric method for analysis of gliclazide in pharmaceutical dosage forms. Int J Pharm Pharm Sci 2011;3 (4):259-60.
Samina A Jamadar, Snehal P Mulye, Poonam S Karekar, Yogesh V Pore, Kishor B Burade. Development and validation of UV spectrophotometric method for the determination of gliclazide in tablet dosage form. Der Pharm Chem 2011;3(4):338-43.
Dhabale PN, Seervi CR. Simultaneous UV spectrophotometric method for estimation of gliclazide and metformine hydrochloride in tablet dosage form. Int J Chem Tech Res 2010;2(2):813-7.
Ketan P Dadhania, Parthika A Nadpara, Yadvendra K Agrawal. Development and validation of spectrophotometric method for simultaneous estimation of gliclazide and metformin hydrochloride in bulk and tablet dosage form by simultaneous equation method. Int J Pharm Sci Res 2011;2(6):1559-63.
Amruta B Loni, Minal R Ghante, Sawant SD. Simultaneous UV spectrophotometric method for estimation of sitagliptin phosphate and metformin hydrochloride in bulk and tablet dosage form. Der Pharm Chem 2012;4(3):854–9.
Hitesh P Inamdar, Ashok A Mhaske. RP-HPLC method for simultaneous determination of metformin hydrochloride, rosiglitazone and sitagliptin–application to commercially available drug products. Int J Pharm Sci Res 2012;3(9):3267-76.
Monila N, Ravi Pratap Pulla, Harshini Shabad, Swathi V, Rajasekhar J, Ramesh A, et al. New extractive method development of sitagliptin phosphate in API and its unit dosage form by spectrophotometry. J Pharm Biol Sci 2012;1(6):37-40.
Patil Sachin L, Bhinge Jayant R, Bhalgat Chetan M. UV spectrophotometric method for simultaneous estimation of sitagliptin and metformin in tablet dosage form. Univ J Pharm 2013;2(1):105-9.
Tarkase KN, Madhuri B Sarode, Sumit A Gulve, Ashwini Gawade. Development and validation of UV spectophotometric method for estimation of sitagliptin phosphate. Der Pharm Lett 2013;5(3):315-8.
Bala Sekaran C, Prameela Rani A. Development and validation of spectrophotometric method for the determination of DPP-4 inhibitor, sitagliptin, in its pharmaceutical dosage forms. Int J Pharm Pharm Sci 2010;2(4):138-42.
Ghazala Khan, Dinesh Sahu, Agrawal YP, Neetu Sabarwal, Avnish Jain, Gupta AK. Simultaneous estimation of metformin and sitagliptin in tablet dosage form. Asian J Biochem Pharm Res 2011;2(1):352-8.
Narendra Nyola, Govinda Samy Jeyabalan. Method development of simultaneous estimation of sitagliptin and metformin hydrochloride in pure and tablet dsoage form by UV-VIS spectroscopy. WJ Pharm Pharml Sci 2012;1(4):1392-401.
Herman G, Bergman A, Liu F, Stevens C, Wang A, Zeng W, et al. Pharmacokinetics and pharmacodynamic effects of the oral DPP-4 inhibitor sitagliptin in middle-aged obese subjects. J Clin Pharmacol 2006;46(8):876-86.
Dubal Anil, Khatwal Rizwanbasha, Kosaraju Jayasankar, Meda Venkat, Samantamalay. Bioanalytical method development and validation of sitagliptin phosphate by RP-HPLC and its application to pharmacokinetic study. Int J Pharm Pharm Sci 2012;4(2):691-4.
Parag Pathade, Imran Md, Vinod Bairagi, Yogesh Ahire. Development and validation of stability indicating UV spectrophotometric method for the estimation of sitagliptin phosphate in bulk and tablet dosage form. J Pharm Res 2011;4(3):871-3.
Ramzia El-bagary I, Ehab Elkady F, Bassam Ayoub M. Spectroflourometric and spectrophotometric methods for the detemination of sitagliptin in binary mixture with metformin and ternary mixture with metformin and sitagliptin alkaline degradation product. Int J Biomed Sci 2011;7(1):62-9.
International Conference on Harmonisation, ICH Harmonised Tripartite Guideline-Validation of Analytical Procedure: methodology. Fed Reg 1997;62;274-93.
ICH, Stability testing, Q1A (R2), Stability Testing of New Drug Substances and Products.