DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH
Keywords:Quality by design, Analytical quality by design, Benidipine hydrochloride estimation, Analytical method validation, Spectrophotometric estimation
Objective: To develop a simple, rapid, accurate, robust and inexpensive spectrophotometric method for the estimation of benidipine hydrochloride by using quality by design (QbD)â€ approach.
Methods: A UV spectrophotometric method was developed on Shimadzu UV-1800 double beam spectrophotometer using methanol as solvent and wavelength of 236 nm was selected as absorbance maxima (ðœ†max). Effect of input variables on spectrum characteristics were studied for the selection of critical parameters and proposed method was validated for various parameters like system suitability, linearity, precision, accuracy, detection limits and quantification limits as per the International Conference on Harmonization guidelines ICH Q2(R1).
Results: Linearity of the method was found to be excellent over the concentration range 3 to 18 Âµg/ml with high correlation coefficient value of 0.9999. Limits of detection and quantification were found to be 0.20 Âµg/ml and 0.60 Âµg/ml respectively. The mean recovery was found to be 100.35 % with low percentage relative standard deviation (% RSD) value. The precision study also has shown low % RSD value (<1). No interfering peaks were observed during specificity studies.
Conclusion: Obtained result indicated that the developed spectrophotometric method is robust and efficient for the determination of benidipine hydrochloride.
Kitakaze M, Karasawa A, Kobayashi H, Tanaka H, Kuzuya T, Hori M. Benidipine: a new Ca 2+channel blocker with a cardioprotective effect. Cardiovasc Drug Rev 1999;17:1â€“15.
Rozet E, Ziemons E, Marini RD, Boulanger B, Hubert P. Quality by design compliant analytical method validation. Anal Chem 2012;84:106â€“12.
ICH Expert Working Group. ICH Harmonised Tripartite Guideline-Pharmaceutical development Q8 (R2). In: Current Step 4 version; 2009. p. 1â€“28.
ICH Expert Working Group. ICH Harmonised Tripartite Guideline-Quality risk management Q9. In: Current Step 4 version; 2005. p. 1â€“23.
ICH Expert Working Group. ICH Harmonised tripartite guideline-pharmaceutical quality system Q10. In: Current Step 4 version; 2008. p. 1â€“21.
ICH Expert Working Group. ICH Harmonised Tripartite Guideline-Validation of analytical procedures: Text and methodology Q2(R1). In: Current Step 4 version; 2005. p. 1â€“17.
McCurdy V. Quality by design. In: Houson I, editor. Process understanding: For scale-up and manufacture of active ingredients. First Edit. Wiley-VCH Verlag GmbH and Co. KGaA; 2011. p. 1â€“16.
Lloyd DK, Bergum J. Application of quality by design (QbD) to the development and validation of analytical methods. In: Riley CM, Rosanske TW, Riley SRR. editors. Specification of drug substances and products: Development and validation of analytical methods. Elsevier; 2014. p. 29â€“72.
Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P, Bormanare P, Hansen G, et al. Implications and opportunities of applying QbD principles to analytical measurements. Pharm Technol 2010;34:12â€“9.
Vogt FG, Kord AS. Development of quality-by-design analytical methods. J Pharm Sci 2011;100:797â€“812.
Musters J, Van Den Bos L, Kellenbach E. Applying QbD principles to develop a generic UHPLC method which facilitates continual improvement and innovation throughout the product lifecycle for a commercial API. Org Proc Res Dev 2013;17:87â€“96.
Hanna Brown M, Borman P, Bale S, Szucs R, Roberts J, Jones C. Development of chromatographic methods using QbD principles. Sep Sci 2010;2:10â€“2.
Ling S, McBrien MA. Quality by design approach to chromatographic method development. LCGC Column 2011;7:16â€“20.
Bhatt DA, Rane SI. QbD approach to analytical RP-HPLC method development and its validation. Int J Pharm Pharm Sci 2011;3:179â€“87.
Karmarkar S, Yang X, Garber R, Szajkovics A, Koberda M. Quality by design (QbD) based development and validation of an HPLC method for amiodarone hydrochloride and its impurities in the drug substance. J Pharm Biomed Anal 2014;100:167â€“74.
Peraman R, Bhadraya K, Padmanabha Reddy Y. Analytical quality by design: a tool for regulatory flexibility and robust analytics. Int J Anal Chem 2015:1â€“9. http://dx.doi.org/ 10.1155/2015/868727.
Jadhav ML, Tambe SR. Implementation of QbD approach to the analytical method development and validation for the estimation of propafenone hydrochloride in tablet dosage form. Chromatogr Res Int 2013:1â€“9. http://dx.doi.org/10.1155/ 2013/676501.
Behera S, Ghanty S, Ahmad F, Santra S, Banerjee S. UV-Visible spectrophotometric method development and validation of assay of paracetamol tablet formulation. J Anal Bioanal Tech 2012;3:1â€“6.
Martins LG, Khalil NM, Mainardes RM. Application of a validated HPLC-PDA method for the determination of melatonin content and its release from poly (lactic acid) nanoparticles. J Pharm Anal 2017;7:388â€“93.
Singh S, Sharma N, Singla YP, Arora S. Development and validation of UV-spectrophotometric method for quantitative estimation of nefopam hydrochloride in polymethacrylate nanospheres. Int J Pharm Pharm Sci 2016;8:414-9.
Ibrahim F, Wahba MEK, Magdy G. Analytical method development and validation of spectrofluorimetric and spectro-photometric determination of some antimicrobial drugs in their pharmaceuticals. Spectrochim Acta Part A Mol Biomol Spectrosc 2018;188:525â€“36.
Chakravarthy A, Sailaja BB, Kumar P. Method development and validation of ultraviolet-visible spectroscopic method for the estimation of assay of sugammadex sodium, apremilast, riociguat, and vorapaxar sulfate drugs in active pharmaceutical ingredient form. Asian J Pharm Clin Res 2017;10:241-50.
Sai Pavan Kumar B, Mathrusri Annapurna M, Pavani S. Development and validation of a stability indicating RP-HPLC method for the determination of rufinamide. J Pharm Anal 2013;3:66â€“70.
Kaur T, Kaur S, Kaur P. Development and validation of UV-spectrophotometric methods for determination of gemcitabine hydrochloride in bulk and polymeric nanoparticles. Int J Appl Pharm 2017;9:60-5.
Kaur S, Bala I, Anjoo Kamboj A, Jain UK. Development and validation of analytical method for estimation of aripiprazole in swab samples on pharmaceutical manufacturing equipment surfaces for cleaning validation. Int J Pharm Pharm Sci 2017;9:141-51.
Prasad AR, Thireesha B. UV-spectrophotometric method development and validation for the determination of lornoxicam in microsponges. Int J Appl Pharm 2018;10:74-8.
Pani NR, Nath L, Singh AV, Mahapatra SK. Development and validation of analytical method for the estimation of nateglinide in rabbit plasma. J Pharm Anal 2012;2:492â€“8.