Author(s):
T. M. Kalyankar, S. J. Wadher, M. R. Bodhankar, Mustasin F Sayed
Email(s):
dr.kalyankartm@gmail.com
DOI:
10.52711/0974-360X.2021.00545
Address:
T. M. Kalyankar*, S. J. Wadher, M. R. Bodhankar, Mustasin F Sayed
Department of Pharmaceutical Chemistry, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 6,
Year - 2021
ABSTRACT:
A novel simple rapid accurate and precise UV spectrophotometric method for simultaneous estimation of bromhexine hydrochloride (BRH) and phenylephrine hydrochloride (PHE) in combine tablet dosage form have been developed. BRH shows absorbance maxima at 246nm and PHE shows 272nm in distilled water after sonication for 20 min. Beer`s law was obeyed at the range of 4-24µg/ml and 5-30µg/ml by BRH and PHE respectively. The method was validated as per ICH guidelines. The validation study data was found to be statistically significant as all the statistical parameters are within the acceptance range (% RSD < 2.0 and S.D. < 2.0) for both accuracy and precision. The force degradation study was carried as per ICH guidelines. The proposed method can be successfully applied for the routine analysis of commercial marked formulation.
Cite this article:
T. M. Kalyankar, S. J. Wadher, M. R. Bodhankar, Mustasin F Sayed. Stability Indicating Simultaneous Estimation of Phenylephrine HCl and Bromhexine HCl in Combined tablet dosage form by UV-Spectrophotometer. Research Journal of Pharmacy and Technology. 2021; 14(6):3128-2. doi: 10.52711/0974-360X.2021.00545
Cite(Electronic):
T. M. Kalyankar, S. J. Wadher, M. R. Bodhankar, Mustasin F Sayed. Stability Indicating Simultaneous Estimation of Phenylephrine HCl and Bromhexine HCl in Combined tablet dosage form by UV-Spectrophotometer. Research Journal of Pharmacy and Technology. 2021; 14(6):3128-2. doi: 10.52711/0974-360X.2021.00545 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-6-35
REFERENCE:
1. British Pharmacopeia Monographs: Medicinal and Pharmaceutical Substances, International ed., Vol. I & II, Her Majesty’s Stationary Office, London, 2009.
2. Mevada DR, Bhalodiya K, Maniar B, Dadhania K, Faldu S. Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Bromhexine Hydrochloride and Phenylephrine Hydrochloride in their Combined Pharmaceutical Dosage Form. Pharma Tutor. 2014: 2(6); 132-138.
3. Anandakumar K, Veerasundari P. Simultaneous estimation of paracetamol, ambroxol hydrochloride, levocetirizine dihydrochloride, and phenylephrine hydrochloride in combined tablet formulation by first-order derivative spectrophotometry. ISRN Spectroscopy. 2014: 2014; 1-8.
4. Wankhede SB, Lad KA, Chitlange SS. Development and validation of UV-spectrophotometric methods for simultaneous estimation of cetirizine hydrochloride and phenylephrine hydrochloride in tablets. International Journal of Pharmaceutical Sciences and Drug Research. 2012: 4(3); 222-226.
5. ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology, Q2 (R1) Geneva. 2005, http://www.ich.org.
6. ICH-Guidelines. Validation of analytical procedures: text and methodology, Q2 (R1). 2005.
7. ICH guideline. Stability testing of new drug substances and products. Q1A (R2). 2003.