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Development and Validation of RP-UHPLC Method for Quantification of Gliclazide in Bulk and Pharmaceutical Dosage Form Using Quality-by-Design (QbD) Approach: A Shifting Paradigm

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Abstract

The current research endeavours quality-by-design (QbD)-aided chromatographic techniques for the quantification of gliclazide (GLZ) in bulk and pharmaceutical dosage forms. Analytical QbD was initiated by assigning both an analytical target profile (ATP) and critical analytical attributes (CAAs). Furthermore, risk evaluation studies, along with factor screening studies, helped identify critical method parameters (CMPs). Optimisation was carried out using a 32 full factorial design by utilising the identified CMP, that is, flow rate (X1) and pH of buffer (X2) at three different levels along with evaluation of the selected CAA, that is, the retention time (Y1) and the peak area (Y2). In addition, the influence of sole and interactive CMPs on CAAs was checked using the data obtained statistically and with response surface plots. The confirmation of significance (P < 0.05) of the method parameters was determined using analysis of variance (ANOVA). Chromatographic separation was achieved using a stainless-steel C8 column (25 cm × 4 mm) in isocratic elution mode using phosphate buffer (pH 3.4) and HPLC-grade acetonitrile (50:50 v/v) as the eluent. The flow rate was adjusted to 1 mL min−1 and the eluent was detected at 230 nm. The validated method, alongside subsequent stress degradation studies conducted according to the ICH guidelines, further favours it as a highly efficient method for the analysis of regular drugs as well as their degraded products. The method proposed above provided a successful demonstration of the QbD-based approach in developing an extremely sensitive and dependable technique for estimating the GLZ for routine analysis and pre-clinical applications.

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All data and materials are available upon request.

Abbreviations

GLZ:

Gliclazide

QbD:

Quality by design

ATP:

Analytical target profile

CAA:

Critical analytical attributes

CMP:

Critical method parameters

ICH:

International Conference on Harmonisation

NIDDM:

Noninsulin-dependent diabetes mellitus

GI:

Gastrointestinal

FEMA:

Failure mode and effective analysis

RP-UHPLC:

Reverse phase ultrahigh pressure liquid chromatography

DAD:

Diode array detector

UV:

Ultraviolet

API:

Active pharmaceutical ingredient

DoE:

Design of experiment

ANOVA:

Analysis of variance

MLRA:

Multiple linear regression analysis

LQC:

Lower quality control

MQC:

Middle quality control

HQC:

Higher quality control

HCl:

Hydrochloric acid

RA:

Risk assessment

References

  1. Sarkar A, Tiwari A, Bhasin PS, Mitra M (2011) Pharmacological and pharmaceutical profile of gliclazide: a review. J Appl Pharm Sci 01(09):11–19

    Google Scholar 

  2. Delrat P, Paraire M, Jochemsen R (2002) Complete Bioavailability and lack of food-effect on pharmacokinetics of gliclazide 30 mg modified release in healthy volunteers. Biopharm Drug Dispos 157(2001):151–157

    Article  Google Scholar 

  3. Sandhu PS, Beg S, Katare OP, Singh B (2016) QbD-driven development and validation of a HPLC method for estimation of tamoxifen citrate with improved performance. J Chromatogr Sci 8:1–12. https://doi.org/10.1093/chromsci/bmw090

    Article  CAS  Google Scholar 

  4. Bonde S, Bonde CG, Prabhakar B (2019) Quality by design based development and validation of HPLC method for simultaneous estimation of paclitaxel and vinorelbine tartrate in dual drug loaded liposomes. Microchem J. https://doi.org/10.1016/j.microc.2019.103982

    Article  Google Scholar 

  5. Manwar JV, Vispute SS, Kumbhar DD, Manmode RS, Bakal RL, Jadhao RG, Jogdand SD (2016) Response surface based optimization of system variables for liquid chromatographic analysis of candesartan cilexetil. Integr Med Res. https://doi.org/10.1016/j.jtusci.2016.02.004

    Article  Google Scholar 

  6. Sangshetti JN, Deshpande M, Arote R, Zaheer Z, Shinde DB (2014) Quality by design approach: regulatory need. Arab J Chem. https://doi.org/10.1016/j.arabjc.2014.01.025

    Article  Google Scholar 

  7. Musters J, Kellenbach E (2013) Applying QbD principles to develop a generic UHPLC method which facilitates continual improvement and innovation throughout the product lifecycle for a commercial API. Org Process Res Dev 17:87–96

    Article  CAS  Google Scholar 

  8. Dangre PV, Phad RD, Surana SJ, Chalikwar SS (2019) Quality by design (QbD) assisted fabrication of fast dissolving buccal film for clonidine hydrochloride: exploring the quality attributes. Adv Polym Technol 2019:1–13

    Article  Google Scholar 

  9. Thakur D, Jain A, Ghoshal G (2016) RP-HPLC method development using analytical QbD approach for estimation of cyanidin-3-O-glucoside in natural biopolymer based microcapsules and tablet dosage form. J Pharm Investig. https://doi.org/10.1007/s40005-016-0269-5

    Article  Google Scholar 

  10. Orlandini S, Pinzauti S, Furlanetto S (2012) Application of quality by design to the development of analytical separation methods. Anal Bioanal Chem. https://doi.org/10.1007/s00216-012-6302-2

    Article  PubMed  Google Scholar 

  11. Parr MK, Schmidt AH (2017) Life Cycle Management of Analytical Methods. J Pharm Biomed Anal. https://doi.org/10.1016/j.jpba.2017.06.020

    Article  PubMed  Google Scholar 

  12. Nina Z, Zdenko C (2020) Development of a stability-indicating analytical method for determination of venetoclax using AQbD principles. ACS Omega. https://doi.org/10.1021/acsomega.0c02338

    Article  Google Scholar 

  13. Hashem H, El-sayed HM (2018) Quality by design approach for development and validation of a RP-HPLC method for simultaneous determination of co-administered levetiracetam and pyridoxine HCl in prepared tablets. Microchem J 143(July):55–63. https://doi.org/10.1016/j.microc.2018.07.031

    Article  CAS  Google Scholar 

  14. Mohammed AQ, Sunkari PK, Srinivas P, Roy AK (2015) Quality by design (QbD) in action-1: controlling critical quality attributes of an active pharmaceutical ingredient (API). Org Process Res Dev 19:1634–1644

    Article  CAS  Google Scholar 

  15. Zhang L, Mao S (2016) Application of quality by design in the current drug development. Asian J Pharm Sci. https://doi.org/10.1016/j.ajps.2016.07.006

    Article  PubMed  PubMed Central  Google Scholar 

  16. Srinubabu G, Raju CAI, Sarath N, Kumar PK, Rao JVLNS (2007) Development and validation of a HPLC method for the determination of voriconazole in pharmaceutical formulation using an experimental design. Talanta 71:1424–1429. https://doi.org/10.1016/j.talanta.2006.04.042

    Article  CAS  PubMed  Google Scholar 

  17. Peraman R, Bhadraya K, Reddy YP, Reddy CS, Lokesh T (2015) Analytical quality by design approach in RP-HPLC method development for the assay of etofenamate in dosage forms. Indian J Pharm Sci 77(March):751–757

    Article  CAS  Google Scholar 

  18. Khamanga SM, Walker RB (2011) The use of experimental design in the development of an HPLC–ECD method for the analysis of captopril. Talanta 83(3):1037–1049. https://doi.org/10.1016/j.talanta.2010.11.025

    Article  CAS  PubMed  Google Scholar 

  19. Krishna MV, Dash RN, Reddy BJ, Venugopal P, Sandeep P, Madhavi G (2013) Quality by design (QbD) approach to develop HPLC method for eberconazole nitrate: application to hydrolytic, thermal, oxidative and photolytic degradation kinetics. J Saudi Chem Soc. https://doi.org/10.1016/j.jscs.2012.12.001

    Article  Google Scholar 

  20. Raul M, Tappin R, Jun M, Carlos A, Lucchetti L (2008) Development of an HPLC method for the determination of tetranortriterpenoids in Carapa guianensis seed oil by experimental design. J Pharm Biomed Anal 48:1090–1095. https://doi.org/10.1016/j.jpba.2008.08.027

    Article  CAS  Google Scholar 

  21. (2005) Requirements for registration of pharmaceuticals for human ICH harmonised tripartite guideline validation of analytical procedures: parent guideline: text on validation of analytical procedures. In: International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, October 1994

  22. Rozet E, Ziemons E, Marini RD, Boulanger B (2012) Quality by design compliant analytical method validation. Anal Chem 84:106–112

    Article  CAS  Google Scholar 

  23. Abergavenny RD, Burnham A, Forest W, Brussels RW (2006) NHS is told to save £2.2bn by being more efficient. BMJ 333(October):873

    Google Scholar 

  24. Services H (2015) Analytical procedures and methods validation for drugs and biologics guidance for industry analytical procedures and methods validation for drugs and biologics guidance for industry. July

  25. Blessy M, Patel RD, Prajapati PN, Agrawal YK (2013) Development of forced degradation and stability indicating studies of drugs—a review. J Pharm Anal. https://doi.org/10.1016/j.jpha.2013.09.003

    Article  PubMed  PubMed Central  Google Scholar 

  26. Pallagi E, Ambrus R, Szabó-révész P, Csóka I (2015) Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation. Int J Pharm. https://doi.org/10.1016/j.ijpharm.2015.06.018

    Article  PubMed  Google Scholar 

  27. (2009) Requirements for registration of pharmaceuticals for human use. In: International Conference on Harmonisation of technical. requirements for registration of pharmaceuticals for human use, 8(August)

  28. Kumar L, Reddy MS, Managuli RS, Girish Pai K (2015) Full factorial design for optimization, development and validation of HPLC method to determine valsartan in nanoparticles. Saudi Pharm J. https://doi.org/10.1016/j.jsps.2015.02.001

    Article  PubMed  PubMed Central  Google Scholar 

  29. Pardeshi CV, Belgamwar VS (2018) N,N,N-Trimethyl chitosan modified flaxseed oil based mucoadhesive neuronanoemulsions for direct nose to brain drug delivery. Int J Biol Macromol. https://doi.org/10.1016/j.ijbiomac.2018.09.032

    Article  PubMed  Google Scholar 

  30. Kumar BSP, Annapurna MM, Pavani S (2013) Development and validation of a stability indicating RP-HPLC method for the determination of rufinamide. J Pharm Anal 3:66–70. https://doi.org/10.1016/j.jpha.2012.08.003

    Article  Google Scholar 

  31. Dey S, Patro SS, Babu NS, Murthy PN, Panda SK (2017) Development and validation of a stability-indicating RP-HPLC method for estimation of atazanavir sulfate in bulk. Journal of Pharmaceutical Analysis 7:134–140. https://doi.org/10.1016/j.jpha.2013.12.002

    Article  CAS  PubMed  Google Scholar 

  32. Ali A, Khan K, Imam SS, Aqil M, Khan A, Sultana Y (2016) Design of experiment based validated stability indicating RP-HPLC method of temozolomide in bulk and pharmaceutical dosage forms. Beni-Suef Univ J Basic Appl Sci 5:402–408. https://doi.org/10.1016/j.bjbas.2015.11.011

    Article  Google Scholar 

  33. Jayagopal B, Shivashankar M (2017) Analytical quality by design—a legitimate paradigm for pharmaceutical analytical method development and validation. Mech Mater Sci Eng J 9:364–373. https://doi.org/10.2412/mmse.96.97.276

    Article  Google Scholar 

  34. Thalla et al (2022) Development & validation of LC-MS/MS method for pyrazinamide estimations from pharmacoengineered lipid core–shell nanoarchitectonics. Acta Chromatogr (in press)

  35. Chaudhari VS et al (2020) Analytical method development & validation of reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous quantifications of quercetin and piperine in dual-drug loaded nanostructured lipid carriers. J Pharm Biomed Anal 186(C):113325

    Article  CAS  Google Scholar 

  36. Banerjee et al (2013) Development and validation of a reverse phase liquid chromatography method for the simultaneous quantification of eserine and pralidoxime chloride in drugs-in-adhesive matrix type transdermal patches. Arzneimittelforschung Drug Res 63:450–456

    CAS  Google Scholar 

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Acknowledgements

The author Ripunjoy Bordoloi is thankful to Assam Science and Technology University (ASTU), Assam, India, and Girijananda Choudhury Institute of Pharmaceutical Science (GIPS), Assam, India, for providing facilities to perform this research work.

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Authors and Affiliations

  1. Assam Science and Technology University (ASTU), Tetelia Road, Jalukbari, Assam, 781013, Guwahati, India

    Ripunjoy Bordoloi

  2. NETES Institute of Pharmaceutical Science, NIPS Mirza, Santipur Kamrup, Assam, 781125, Guwahati, India

    Ripunjoy Bordoloi

  3. Girijananda Choudhury Institute of Pharmaceutical Science, Tezpur, Assam, 784501, India

    Abdul Baquee Ahmed

  4. Regional Drugs Testing Laboratory, Six Mile, Guwahati, Assam, 781022, India

    Himakshi Baishya

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  1. Ripunjoy Bordoloi
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  3. Himakshi Baishya
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Contributions

ABA carried out designing of the current study. RB and HB carried out the experimental work. RB drafted the manuscript and participated in the design and coordination of the manuscript. ABA and HB reviewed the manuscript. All authors read and approved the final manuscript.

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Correspondence to Ripunjoy Bordoloi.

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Bordoloi, R., Ahmed, A.B. & Baishya, H. Development and Validation of RP-UHPLC Method for Quantification of Gliclazide in Bulk and Pharmaceutical Dosage Form Using Quality-by-Design (QbD) Approach: A Shifting Paradigm. Chromatographia 85, 719–732 (2022). https://doi.org/10.1007/s10337-022-04175-7

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