Analytical method development of pitavastatin-loaded SNEDDS formulation: Multivariate analysis regarding ultraviolet spectrophotometry analysis

Abdul Rohman.(1*)

(1) Scopus ID: 32668020600, Fakultas Farmasi, Universitas Gadjah Mada
(*) Corresponding Author


Herein, this work aimed to develop and assess feasibility of multivariate model of partial least square analysis for specific quantification of pitavastatin (PVT)-loaded self-nano emulsion (SNE) formulation using UV-Vis spectrophotometry.

    PVT loaded into self-nano emulsion formulation comprising of Capryol-90, Tween 80, and Transcutol P under different loading levels i.e. 10-90 mg/mL. All samples scanned using UV-Vis spectrophotometer from 300-200 nm. PVT and SNE were prepared separately for estimation of interference. Multivariate model was constructed using partial least square (PLS) regression analysis as well as principal component analysis for qualitative pattern recognition. Cross-validation using a leave one out technique and goodness of fit parameters were applied for model evaluation.

    The results revealed that maximum sensitivity of PVT was obtained at 244 nm. SNE formulation had different interference value and decreased exponentially as increasing the PVT loading in the SNEDDS formulation. The highest drug loading had an interference value of 7.11%. Therefore, the SNEDDS formulation interfered the PVT quantification and mainly depended on the drug loading. Finally, multivariate analysis, PLS could be applied to eliminate the placebo/formulation interference for PVT quantification independently towards drug loading level.

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Badawy, M.E.I., Saad, A.-F.S.A., Tayeb, E.-S.H.M., Mohammed, S.A., Abd-Elnabi, A.D., 2017. Optimization and characterization of the formation of oil-in-water diazinon nanoemulsions: Modeling and influence of the oil phase, surfactant and sonication. J. Environ. Sci. Health Part B 52, 896–911.

Bandyopadhyay, S., Katare, O.P., Singh, B., 2014. Development of optimized supersaturable self-nanoemulsifying systems of ezetimibe: effect of polymers and efflux transporters. Expert Opin. Drug Deliv. 11, 479–492.

Cağlar, S., Oztunç, A., 2007. A sensitive spectrophotometric method for the determination of desloratadine in tablets. J. AOAC Int. 90, 372–375.

Chavan, R.B., Modi, S.R., Bansal, A.K., 2015. Role of solid carriers in pharmaceutical performance of solid supersaturable SEDDS of celecoxib. Int. J. Pharm. 495,374–384.

Choiri, S., Ainurofiq, A., Ratri, R., Zulmi, M.U., 2018. Analytical method development of nifedipine and its degradants binary mixture using high performance liquid chromatography through a quality by design approach. IOP Conf. Ser. Mater. Sci. Eng. 333, 012064.

Dastidar, D.G., Sa, B., 2009. A Comparative Study of UV-Spectrophotometry and First-Order Derivative UV-Spectrophotometry Methods for the Estimation of Diazepam in Presence of Tween-20 and Propylene Glycol. AAPS PharmSciTech 10.

Efiana, N.A., Mahmood, A., Lam, H.T., Zupančič, O., Leonaviciute, G., Bernkop-Schnürch, A., 2017. Improved mucoadhesive properties of self-nanoemulsifying drug delivery systems (SNEDDS) by introducing acyl chitosan. Int. J. Pharm.519,206–212.

El-Enany, N., El-Sherbiny, D., Belal, F., 2007. Spectrophotometric, spectrofluorometric and HPLC determination of desloratadine in dosage forms and human plasma. Chem. Pharm. Bull. (Tokyo) 55, 1662–1670.

Fukuda, I.M., Pinto, C.F.F., Moreira, C. dos S., Saviano, A.M., Lourenço, F.R., 2018. Design of experiments (DoE) applied to pharmaceutical and analytical quality by besign (QbD). Braz. J. Pharm. Sci. 54.

Grobelny, P., Viola, G., Vedaldi, D., Dall’Acqua, F., Gliszczyńska-Świgło, A., Mielcarek, J., 2009. Photostability of pitavastatin—A novel HMG-CoA reductase inhibitor. J. Pharm. Biomed. Anal., 50, 597–601.

Krishna, M.V., Sankar, D.G., 2007. Adaptation of color reactions for spectrophotometric determination of pitavastatin calcium in bulk drugs and in pharmaceutical formulations. E-J. Chem. 4, 272–278.

Kukrety, A., Kohli, K., Singhal, M., Dhal, C., Chauhan, A., Arora, P.K., Singh, R.M., Mathur, S.C., Singh, G.N., 2015. Development and validation of a sensitive spectrophotometric method for simultaneous estimation of pitavastatin calcium and fenofibrate. Indian Drugs 52, 17–21.

Kurniawati, E., Rohman, A., Triyana, K., 2014. Analysis of lard in meatball broth using Fourier transform infrared spectroscopy and chemometrics. Meat Sci. 96, 94–98.

Liudmil Antonov, Stefan Stoyanov, 1993. Analysis of the Overlapping Bands in UV-Vis Absorption Spectroscopy. Appl. Spectrosc. 47, 1030–1035.

Redasani, V.K., Patel, P.R., Marathe, D.Y., Chaudhari, S.R., Shirkhedkar, A.A., Surana, S.J., 2018. A review on derivative Uv-spectrophotometry analysis of drugs in pharmaceutical formulations and biological samples review. J. Chil. Chem. Soc. 63, 4126–4134.

Rehman, F.U., Shah, K.U., Shah, S.U., Khan, I.U., Khan, G.M., Khan, A., 2017. From nanoemulsions to self-nanoemulsions, with recent advances in self-nanoemulsifying drug delivery systems (SNEDDS). Expert Opin. Drug Deliv. 14, 1325–1340.

Rohman, A., Man, Y.B.C., 2012. Application of Fourier Transform Infrared Spectroscopy for Authentication of Functional Food Oils. Appl. Spectrosc. Rev. 47, 1–13.

Rohman, A., Sismindari, null, Erwanto, Y., Che Man, Y.B., 2011. Analysis of pork adulteration in beef meatball using Fourier transform infrared (FTIR) spectroscopy. Meat Sci. 88, 91–95.

Saffari, M., Ebrahimi, A., Langrish, T., 2016. A novel formulation for solubility and content uniformity enhancement of poorly water-soluble drugs using highly-porous mannitol. Eur. J. Pharm. Sci. 83, 52–61.

Sahu, P.K., Ramisetti, N.R., Cecchi, T., Swain, S., Patro, C.S., Panda, J., 2017. An overview of experimental designs in HPLC method development and validation. J. Pharm. Biomed. Anal.

Takano, D.E.N., de Souza Reis, P.R., Singh, A.K., Lourenço, F.R., 2017. Estimation of uncertainty for measuring desloratadine in tablets formulation using UV spectrophotometry. Measurement 101, 40–44.

Vadia, N., Patel, V., Bhalara, H., 2008. Spectrophotometric determination of cefetamet pivoxil hydrochloride and pitavastatin calcium in tablet dosage form. Indian J. Pharm. Sci. 70, 649–651.


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