DEVELOPMENT AND VALIDATION OF A HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY FOR THE DETERMINATION OF TERBUTALINE SULFATE, BROMHEXINE HYDROCHLORIDE, AND ETOPHYLLINE IN PHARMACEUTICAL DOSAGE FORM
DOI:
https://doi.org/10.22159/ajpcr.2019.v12i9.32312Keywords:
Terbutaline sulfate, Bromhexine hydrochloride,, Etophylline, High-performance thin-layer chromatography, ICH guidelines, Simultaneous estimation, TabletAbstract
Objective: The study aimed to development and validation of simple, precise, and reliable high-performance thin-layer chromatography (HPTLC) for the determination of terbutaline sulfate (TBS), bromhexine hydrochloride (BRH), and etophylline (ETP) in pharmaceutical dosage form.
Methods: A simple, precise, rapid, and accurate HPTLC method was developed for the estimation of TBS, BRH, and ETP in pharmaceutical dosage form. Pre-coated silica gel G60 F254 aluminum sheet (10 cm2×10 cm2 and thickness 0.2 mm) was used as stationary phase while mobile phase consisting of benzene: methanol:glacial acetic acid 8:0.5:1.5 v/v/v detection at 275 nm. The present method had validated according to ICH guidelines.
Results: Migration distance found 80 mm at 275 nm. The retention factor found to be 0.24, 0.57, and 0.68, respectively. The detector response was linear in the concentration range of 60–210 ng/band, 2400–8400 ng/band, and 96–336 ng/band, respectively. The linear regression equation being Y=32.20x−562.9, Y=11.79x−1711, and Y=1.756x−5636, respectively. The limit of detection for TBS 0.677 μg, for BRH 8.123 μg, and for ETP 57.915 μg and limit of quantification to be 2.053, 24.617, and 175.5 μg, respectively, were found. The developed method validated by ICH guideline, i.e., accuracy, precision, robustness, specificity, and system suitability.
Conclusion: In this study, we had developed a simple, fast, and reliable HPTLC method for the determination of TBS, BRH, and ETP in pharmaceutical dosage form.
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References
Dave HN, Mashr RC, Patel AK. Thin layer chromatography method for the determination of ternary mixture containing salbutamol sulphate, bromhexine hydrochloride and etofylline. Int J Pharm Sci Res 2010;2:143-8.
Sumarlik E, Indrayanto G. TLC densitometric determination of bromhexine hydrochloride in pharmaceuticals, and its validation. J Liq Chromatogr Relat Technol 2004; 27:2047-56.
Dhoka MV, Gawande VT, Joshi PP. HPTLC determination of amoxicillin trihydrate and bromhexine hydrochloride in oral solid dosage forms. J Pharm Sci Res 2010;2:477-83.
Faiyazuddin M, Rauf A, Ahmad N, Ahmad S, Iqbal Z, Talegaonkar S, et al. A validated HPTLC method for determination of terbutaline sulfate in biological samples: Application to pharmacokinetic study. Saudi Pharm J 2011;19:185-91.
Faiyazuddin M, Ahmad S, Iqbal Z, Talegaonkar S, Ahmad FJ, Bhatnagar A, et al. Stability indicating HPTLC method for determination of terbutaline sulfate in bulk and from submicronized dry powder inhalers. Anal Sci 2010;26:467-72.
Rao MR, Kumar M, Aghav S, Sukre G. Development and validation of HPTLC method for determination of bromhexine hydrochloride in human plasma. Res J Pharm Technol 2012;5:1054-7.
Awotwe-Otoo D, Agarabi C, Faustino PJ, Habib MJ, Lee S, Khan MA, et al. Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate. J Pharm Biomed Anal 2012;62:61-7.
Sheladia S, Patel B. Implementation of QBD approach to develop and validate analytical method for simultaneous estimation of duloxetine hydrochloride and methylcobalamine in pharmaceutical dosage form by HPTLC method. Int J Pharm Pharm Sci 2016;8:105-13.
Bhatt DA, Rane SI. QBD approach to analytical RPHPLC method development and its validation. Int J Pharm Pharm Sci 2011;3:179-87.
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