Development and validation of stability indicating UPLC method for the simultaneous estimation of triamterene and hydrochlorothiazide in combined dosage forms using quality by design approach

Development and validation of stability indicating UPLC method for the simultaneous estimation of triamterene and hydrochlorothiazide in combined dosage forms using quality by design approach D. Akila Devi P. Geetha Bhavani Abstract Background

According to the information gathered from the literature, no technique for UPLC of triamterene and hydrochlorothiazide employing QbD in the formulations has been published. The technique development by incorporating QbD and validating for accuracy, linearity, precision, LOQ, LOD, ruggedness and selectivity as per ICH is part of the work’s modernity.
Results

Screening investigations led to the selection of cmps. Peak tailing was evaluated as a metric of technique robustness based on these important analytical attributes, namely retention time. With a 0.1 percent OPN: methanol (40:60) mobile phase, a flow rate of 0.3 ml/min, a wave length of 224 nm, an injection volume of 41, and a run time of 6 min, the best chromatographic separation was attained.
Conclusions

The method was verified using ICH criteria, which ensure a high level of linearity, accuracy, precision, specificity and robustness. As a result, the suggested approach is regarded as a quick and accurate method for estimating triamterene and hydrochlorothiazide at the same time.
02 01 2023 9 438 1 10.1007/springer_crossmark_policy link.springer.com false 7 June 2022 4 November 2022 1 February 2023 Not applicable. Not applicable. The authors declare that they have no competing interests. https://creativecommons.org/licenses/by/4.0 https://creativecommons.org/licenses/by/4.0 10.1186/s43094-022-00438-0 20230201120502479 https://fjps.springeropen.com/articles/10.1186/s43094-022-00438-0 https://link.springer.com/content/pdf/10.1186/s43094-022-00438-0.pdf https://link.springer.com/content/pdf/10.1186/s43094-022-00438-0.pdf https://link.springer.com/article/10.1186/s43094-022-00438-0/fulltext.html Santhosh SB, Sachin LD (2019) Analytical method development and optimization of Sofosbuvir drug: a QbD approach. IJPSR 10(1) Indian J Pharm Sci R Peraman 77 6 751 2015 10.4103/0250-474X.174971 Peraman R, Bhadraya K, Padmanabha Reddy Y, Surayaprakash Reddy C, Lokesh T (2015) Analytical quality by design approach in RP-HPLC method development for the assay of etofenamatein dosage forms. Indian J Pharm Sci 77(6):751–757 Org Process Res T Tome 23 1784 2019 10.1021/acs.oprd.9b00238 Tome T, Zigart N, Casar Z (2019) Development and optimization of liquid chromotography analytical methods by using AQbD principles: overview and recent advances. Org Process Res 23:1784–1802 Acta Pharmaceutica SS AbD El-Hay 16 1 109 2016 10.1515/acph-2016-0022 AbD El-Hay SS, ZHashem H (2016) High performance liquid chromatography for and simultaneous determination of performance liquid chromotography for simultaneous determination of xipimide, triamterene and hydrochlorothaizide in bulk drug samples and dosage forms. Acta Pharmaceutica 16(1):109 Pharma Tutor Mag VC Chauhan 2 115 2014 Chauhan VC, Shah VN, Shah DA, Parmar RR (2014) Development and Validation of RP-HPLC Method for simultaneous Estimation of Triamterene and Benzthiazide in Tablets. Pharma Tutor Mag 2:115 RJPT S Antakli 11 6 115 2018 10.5958/0974-360X.2018.00436.5 Antakli S, Nejem L, Kullah A (2018) Analytical spectrophotometric study for determining hydrochlorothiazide individually or with combination with triamterene in some pharmaceutical formulations. RJPT 11(6):115 IJRPC C Manisha 392 151 2013 Manisha C (2013) Significance of various chromotographic techniques in drug discovery and developmen. IJRPC 392:151 AJAPC M Taleuzzaman 2 1056 2016 Taleuzzaman M (2016) Ultra performance liquid chromotography. AJAPC 2:1056 EJBPS R Priyadarshini 3 366 2016 Priyadarshini R (2016) Chromotography the essence of bioanalysis. EJBPS 3:366–377 IJPS S Sharath Chandra 21 237 2013 Sharath Chandra S (2013) Switch from HPLC to UPLC: a novel achivement in liquid chromotography techniques. IJPS 21:237–246 CPA K Rajneet 3 180 2015 Rajneet K (2015) Analytical quality by design approach for development of a validate bioanalytical UPLC method of docetaxel trihhdrate. CPA 3:180 IJDDR V Pavan Kumar 17 0 2015 Pavan Kumar V (2015) Quality by design approach QBD for pharmaceuticals. IJDDR 17:0 IJAC P Ramalingam 2015 10.1155/2015/868727 Ramalingam P (2015) Analytical quality by design: a tool for regulatory flexibility and robust analytics. IJAC. https://doi.org/10.1155/2015/868727 JCS S Karmakar 49 439 2011 Karmakar S (2011) Quality by design [QbD ] based development of a stability indicating HPLC method for drug and impurities. JCS 49:439 AJAPC NS Tharkor 4 1078 2017 Tharkor NS (2017) Implementing quality by design [QbD] in chromotography. AJAPC 4:1078 ICH Guidelines