Author(s): Khushbu Patel, Ujashkumar A. Shah, Hirak V. Joshi, Jayvadan K. Patel, Chhaganbhai N. Patel

Email(s): khushbusspc@gmail.com

DOI: 10.52711/0974-360X.2022.00319   

Address: Khushbu Patel1,2*, Ujashkumar A. Shah3, Hirak V. Joshi3, Jayvadan K. Patel3, Chhaganbhai N. Patel1
1Department of Quality Assurance and Pharmaceutical Chemistry, Shri Sarvajanik Pharmacy College, Near Arvind Bag, Mahesana - 384001, Gujarat, India.
2Research Scholar, Sankalchand Patel University, S. K. Campus, Kamana Cross Road, Visnagar - 384315, Gujarat, India.
3Department of Quality Assurance and Pharmaceutical Chemistry, Nootan Pharmacy College, Sankalchand Patel University, S. K. Campus, Kamana Cross Road, Visnagar-384315, Gujarat, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 5,     Year - 2022


ABSTRACT:
A new simple stability indicating reverse phase liquid chromatography method was developed by employing Quality by Design (QbD) approach for the simultaneous determination of Linagliptin and Metformin HCl. Within QbD paradigm, the present study aimed to establish the optimization of the RP-HPLC (Reverse phase high performance liquid chromatography) by means of design of experiments and response surface mythology like, Centre composite design (CCD) in order to achieve a good separation and resolution. The developed method is effective to separate Linagliptin and Metformin HCl with a good chromatographic resolution of 6.4. Chromatographic separation was acquired with column Water C18 (250mm x 4.5mm x 5µm) at flow rate 1.0 ml/min with the mobile phase consists of acetonitrile and methanol (75:25 % v/v). The detection of Linagliptin and Metformin HCl was carried out at 245nm. The proposed method was validated according to ICH guidelines. The method was linear in range of 0.5-3µg/ml and 100-600µg/ml of Linagliptin and Metformin HCl respectively and recovery were in the range of 98% to 102%. The degradation product found in stress patterns were well separated among the drug compounds. The method was validated to be specific, rapid, precise and robust for routine analysis in its pharmaceutical dosage form.


Cite this article:
Khushbu Patel, Ujashkumar A. Shah, Hirak V. Joshi, Jayvadan K. Patel, Chhaganbhai N. Patel. QbD Stressed Development and Validation of Stability-Indicating RP- HPLC Method for the Simultaneous Estimation of Linagliptin and Metformin HCl in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(5):1917-3. doi: 10.52711/0974-360X.2022.00319

Cite(Electronic):
Khushbu Patel, Ujashkumar A. Shah, Hirak V. Joshi, Jayvadan K. Patel, Chhaganbhai N. Patel. QbD Stressed Development and Validation of Stability-Indicating RP- HPLC Method for the Simultaneous Estimation of Linagliptin and Metformin HCl in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(5):1917-3. doi: 10.52711/0974-360X.2022.00319   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-5-1


REFERENCES:
1.    Linagliptin, [cited 2020 Oct 17]. https://medlineplus.gov/druginfo/meds/a611036.html
2.    Metformin, [cited 2020 Oct 17]. https://www.webmd.com/drugs/2/drug-11285-7061/metformin-oral/metformin-oral/details.
3.    Linagliptin, Drug Bank. [cited 2020 Oct 17]. Available from: https://go.drugbank.com/drugs/DB08882.
4.    Metformin, Drug Bank. [cited 2020 Oct 17]. Available from: https://go.drugbank.com/drugs/DB00331.
5.    ICH, Q8(R2), Harmonized Tripartite Guideline, Pharmaceutical Development. Available from:https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf.
6.    Astha P. Sanyal, Khushbu K. Patel, Ushma B. Patel and Dr. Chhaganbhai N. Patel. Analytical Method Development and Validation for Estimation of Saroglitazar Magnesium in Pharmaceutical Dosage Form by Quality by Design Approach. World Journal of Pharmaxy and Pharmaceutical Sciences, 2020; 9(4):1267-1281.
7.    ICH, Q1A(R2): Stability Testing of New Drug Substance and Drug Product. Available from:https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf.
8.    Saroj Gajare, Vedantika Das, Ashwini Sambherao, Amar Zalte, Ravindra B. Saudagar. Development and Validation of Linagliptin and Metformin hydrochloride in Bulk and Combined Tablet Dosage Form by using UV Spectrophotometric Method. Asian Journal of Pharmaceutical Analysis. 2017; 7(2): 141-144. 10.5958/2231-5675.2017.00022.9
9.    M. Mallikarjuna, C. Guru Sudhakar, K. Siva Shankar, SK. Abid, P. Rameeja. Development and Validation of a New Method for the Simultaneous Estimation of Metformin and Linagliptin in Bulk and Dosage form by using UV–Spectrophotometry. Asian Journal of Chemistry and Pharmaceutical Research. 2018; 6(1):58-72.
10.    Sivagami, B., Purushotham, A., Sikdar, P., Chandrasekar, R., & Babu, M. N. A Validated Method for The Simultaneous Estimation of Linagliptin and Metformin in Tablet Dosage Forms by RP-HPLC. Research Journal of Pharmaceutical Technology. 2020; 13(3): 1266-1270. 10.5958/0974-360X.2020.00233.4
11.    A. Janardhan Swamy, K. Harinadha Baba. Analytical Method development and Method validation for the simultaneous estimation of Metformin HCL and Linagliptin in Bulk and tablet Dosage Form by RP-HPLC Method.  International Journal of Pharmacy. 2013; 3(3): 594-600.
12.    S. Hari Hara Kumar, S. Sai Kiran. Method development and validation of metformin and linagliptin by RP-HPLC method in pharmaceutical dosage form. International Journal of Innovative Pharmaceutical Sciences and Research, 2016; 4(4); 333-339.
13.    El-Bagary RI, Elkady EF, Ayoub BM. Spectrophotometric Methods for the Determination of Linagliptin in Binary Mixture with Metformin Hydrochloride and Simultaneous Determination of Linagliptin and Metformin Hydrochloride using High Performance Liquid Chromatography. International Journal of Biomedical Sciences. 2013; 9(1): 41-47.
14.    Sohan S. Chitlange, Mohammed Imran, Kiran Bagri, DM Sakarkar. A stability-indicating reverse phase high performance liquid chromatography method for the simultaneous determination of ramipril and valsartan in pharmaceutical dosage form. Research J. Pharm. and Tech. 2008;1(3): 215-217.
15.    B. Thangabalan, M. Salomi, N. Sunitha, S. Manohar Babu. Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical dosage form. Asian J. Pharm. Ana. 2013;3(4):119-123.
16.    N. Sunitha, L. Sindhura, B. Thangabalan, S. Manohar Babu. Development and Validation of RP–HPLC Method for Simultaneous Estimation of Cefepime and Tazobactam in Injection Formulation. Asian J. Pharm. Ana. 2013; 3(4):131-137.
17.    H.I. Pawar, Lata Kothapalli, Asha Thomas, R.K Nanda, Shivaji Mare. Simultaneous RP-HPLC Method for Estimation of Ezetimibe and Fenofibrate in Synthetic mixture. Research J. Pharm. and Tech. 2008;1(1):25-28.
18.    Srivani, J., B. Umamahesh, and C. Veeresham. Development and Validation of Stability Indicating HPTLC Method for Simultaneous Determination of Linagliptin and Metformin. International Journal of Pharmacy and Pharmaceutical Sciences. 2015; 8(1): 112-115.
19.    Abbas Moussa B, Mahrouse MA, Fawzy MG. A validated LC-MS/MS method for simultaneous determination of linagliptin and metformin in spiked human plasma coupled with solid phase extraction: Application to a pharmacokinetic study in healthy volunteers. Journal of Pharmaceutical Biomedical Analysis. 2019; 163: 153-161. 10.1016/j.jpba.2018.09.052
20.    Kavitha. K. Y, Geetha. G., et.al. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of linagliptin and metformin in pure and pharmaceutical dosage form. Journal of Chemistry and Pharmaceutical Research. 2013; 5(1): 230-235.
21.    Nagunath Sirigiri, Siva Subramanian N, Naveen Kumar Reddy G. Stability Indicating Method Development and Validation for Simultaneous Estimation of Linagliptin and Metformin HCl in Tablets by HPLC.  Der Pharma Chemistry. 2017; 9(21):100-106.
22.    Jadhav SB, Reddy PS, Narayanan KL, Bhosale PN. Development of RP-HPLC, Stability Indicating Method for Degradation Products of Linagliptin in Presence of Metformin HCl by Applying 2 Level Factorial Design; and Identification of Impurity-VII, VIII and IX and Synthesis of Impurity-VII. Sciences Pharma. 2017; 85(3): 25-28. 10.3390/scipharm85030025
23.    T.M. Kalyankar, R.B. Kakde. Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Metformin and Repaglinide in Pharmaceutical Preparations. Research J. Pharma. Dosage Forms and Tech. 2011; 3(5): 233-237.
24.    Dhavale Sushant, Jagtap Rajesh, Kotkar Tushar, Bhosale AV, Hardikar SR. Formulation and Evaluation of Floating Sustained Drug Delivery for Metformin HCl Using Combination of Natural and Synthetic Polymers. Research J. Pharma. Dosage Forms and Tech. 2009; 1(3):244-249.
25.    Ganesh S Shinde, Godge Rahul K , Ravindra Jadhav. Quantitative Estimation and Validation of Metformin Hydrochloride and Gliclazide in their Tablet Dosage Form by RP-HPLC. Research J. Science and Tech. 2019; 11(3):201-207. 10.5958/2349-2988.2019.00030.5
26.    Rahul K. Godge, Ganesh S. Shinde, Shraddha Joshi. Simultaneous Estimation and Validation of Dapagliflozin and Saxagliptin in Bulk Drug and Dosage Form by RP-HPLC. Research J. Science and Tech. 2019; 11(1):59-63. 10.5958/2349-2988.2019.00008.1
27.    Parthiban C., Bhagavan Raju M., Sudhakar M. A Novel Simultaneous Estimation of Metformin, Glimepiride and Rosiglitazone in Tablet Dosage Form by RP-HPLC Method. Research J. Pharm. and Tech. 2011; 4(10):1576-1580.
28.    ICH, Q2(R1): Validation of Analytical Procedure: Text and Methodology. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available