Open Access
Subscription Access
Open Access
Subscription Access
Development and Validation of a Robust RP-HPLC Method for Analysis of Calcipotriol in Pharmaceutical Dosage Form
Subscribe/Renew Journal
Calcipotriol is a very efficient drug used in the treatment of psoriasis. In present work a novel, hasty, effortless and cost-effective Reversed -Phase High-Performance Thin-Layer Chromatography (RP-HPTLC) technique has been developed and subsequently validated for quantitative assessment of calcipotriol in bulk and in ointment. Optimized chromatographic condition was employed to accomplish separation on a Phenomenex Luna C18 column (250mm X 4.6 mm in diameter) with typical particle size of 5μ column employing Shimadzu HPLC system. Mobile phase constituting of methanol: water (80:20, v/v) was pumped during the chromatographic separation at 1 mL/min flow rate and detection was made by ultraviolet‑visible detector at 264 nm. The method was validated for linearity, precision, robustness, accuracy, limit of detection and limit of quantification as per guidelines of International conference on Harmonization (ICH). The method resulted into sharp and well resolved peak for Calcipotriol at 8.2 min retention time. Method was also found to be linear (regression coefficient: 0.999), accurate (average recovery: 100%), precise and robust. Thus the developed analytical method is acceptable for identification and quantitative estimation of calcipotriol in bulk formulation and ointment formulation.
Keywords
Calcipotriol, Liquid Chromatography, Validation, Retention Time.
Subscription
Login to verify subscription
User
Font Size
Information
- Pradhan M, Singh D, Singh MR. Fabrication, optimization and characterization of Triamcinolone acetonide loaded nanostructured lipid carriers for topical treatment of psoriasis: Application of Box Behnken design, in vitro and ex vivo studies. J Drug Deliv Sci Technol. 2017; 41: 325-333.
- Pradhan M, Singh D, Singh MR. Novel colloidal carriers for psoriasis: Current issues, mechanistic insight and novel delivery approaches. J Control Release. 2013;170(3):380-95.
- Knudsen NØ, Rønholt S, Salte RD, Jorgensen L, Thormann T, Basse LH, et al., Calcipotriol delivery into the skin with PEGylated liposomes. Eur J Pharm Biopharm. 2012;81(3):532-9.
- Varma NSK, PV Maheshwari, M Navya, SC Reddy, Shivakumar HG, Gowda DV. Calcipotriol delivery into the skin as emulgel for effective permeation. Saudi Pharm J. 2014;22(6):591-9.
- Bury Y, Ruf D, Hansen CM, Kissmeyer AM, Binderup L, Carlberg C. Molecular evaluation of vitamin D3 receptor agonists designed for topical treatment of skin diseases. J Invest Dermatol. 2001;116(5):785-92.
- Hegyi Z, Zwicker S, Bureik D, Peric M, Koglin S, Batycka-Baran A, et al., Vitamin D analog calcipotriol suppresses the Th17 cytokine-induced proinflammatory S100 "alarmins" psoriasin (S100A7) and koebnerisin (S100A15) in psoriasis. J Invest Dermatol. 2012;132(5):1416-24.
- Cirunay JJ, Vander HY, Plaizier-Vercammen J. LC separation of calcipotriol from its photodegradation products and protection possibilities using adjuvants. J Pharm Biomed Anal. 2001;26(1):31-41.
- Singh M, Charde RM, Charde MS. Determination of Calcipotriene and forced its degradation behavior by HPLC. J Pharm Res. 2011;4(3):845-847.
- Roy C, Chakrabarty J, Ratti RR. Development and validation of a stability-indicating NP-HPLC method for simultaneous determination of betamethasone dipropionate and calcipotriene in topical dosage form. Arch Appl Sci Res. 2013; 5 (2):15-24.
- Chonkar AD, Managuli RS, Rao JV, Udupa N. Development and validation of reversed phase high-performance liquid chromatography method for estimation of lercanidipine HCl in pure form and from nanosuspension formulation. J Basic Clin Pharm. 2016; 7(1): 17–22.
- Bhagawati ST, Reddy MS, Avadani K, Muddukrishna BS, Dengale SJ, Bhat K. Development and validation of reversed‑phase high‑performance liquid chromatography method for estimation of rizatriptan benzoate in oral strip formulations. J Basic Clin Pharm. 2014;6:7‑11.
- Johnston SE, Gill NL, Wei YC, Markovich R, Rustum AM. Development and validation of a stability-indicating RP-HPLC method for simultaneous assay of betamethasone dipropionate, chlorocresol, and for the estimation of betamethasone dipropionate related compounds in a pharmaceutical cream and ointment. J Chromatogr Sci. 2010;48(9):733-41.
- Dey S, Subhasis Patro S, Suresh Babu N, Murthy PN, Panda SK. Development and validation of a stability-indicating RP-HPLC method for estimation of atazanavir sulfate in bulk. J Pharm Anal. 2017;7(2):134-140.
- Épshtein NA. Structure of chemical compounds, methods of analysis and process control validation of HPLC techniques for pharmaceutical analysis. Pharm Chem J. 2004;38:40‑56.
- Bavand SM, Vahidi H, Ayatollahi AM, Hooshfar S, Kobarfard F. RP-HPLC Method Development and Validation for Determination of Eptifibatide Acetate in Bulk Drug Substance and Pharmaceutical Dosage Forms. Iran J Pharm Res. 2017;16(2):490-497
- Patel RA, Shah CN. Method validation and method development by using analytical method HPLC- Review on Current Research. J Pharm Sci Bioscientific Res. 2016;6(5):728-732.
- Pérez‑Lozano P, García‑Montoya E, Orriols A, Miñarro M, Ticó JR, Suñé‑Negre JM. Development and validation of a new HPLC analytical method for the determination of alprazolam in tablets. J Pharm Biomed Anal. 2004;34:979‑87.
- Solon LG, Lima IP, Nogueira FH, de Araújo JP, Vivacqua CA, Aragão CF. Development and validation of an UHPLC method for the determination of betamethasone valerate in cream, gel, ointment and lotion. Steroids. 2016;106:70-7.
Abstract Views: 233
PDF Views: 0