METHOD DEVELOPMENT AND FORCE DEGRADATION STUDIES FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULFATE, ETOFYLLINE AND BROMHEXINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

  • Nutan Rao Department of Pharmaceutical Chemistry and Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai – 400 705, Maharashtra, India.
  • Kajal D Gawde Department of Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai – 400 705, Maharashtra, India.

Abstract

Objective: The present study describes the stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of salbutamol sulfate (SAL), etofylline (ETO), and bromhexine hydrochloride (BROM) in pharmaceutical dosage forms.

Methods: The proposed RP-HPLC method was developed using Shimadzu prominence-i LC-2030 HPLC system equipped with ultraviolet (UV) detector and chromatographic separation was achieved isocratically using Shim-pack C18 (250 mm×4.6mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 13 min. The mobile phase consisted of acetonitrile: 0.1M potassium dihydrogen phosphate buffer (35:65) with pH adjusted to 3.0 and eluents were scanned using UV detector at 225 nm.

Result: The retention time of SAL, ETO, and BROM was found to be 2.319 min, 2.698 min, and 10.329 min, respectively. The calibration curve was linear over the concentration ranges of 1.6–3.2 μg/ml, 160–320 μg/ml, and 6.4–12.8 μg/ml for SAL, ETO, and BROM, respectively.

Conclusion: The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, humidity, and photo- and thermal degradation and the degraded products formed were resolved successfully from the samples. Therefore, the proposed method can be used as a more convenient and efficient option for the simultaneous estimation of all the three drugs in bulk and combined

Keywords: Salbutamol sulfate, Etofylline, Bromhexine hydrochloride, RP-HPLC, Validation, Forced degradation.

Author Biography

Nutan Rao, Department of Pharmaceutical Chemistry and Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai – 400 705, Maharashtra, India.
Department of Pharmaceutical Chemistry and Quality Assurance, Assistant Professor

References

1. Vijayan VK. Chronic obstructive pulmonary disease. Indian J Med Res 2013;137:251-69.
2. Tripathi KD. Essentials of Medical Pharmacology. New Delhi: JP. Medical Ltd.; 2013.
3. International Conference on Harmonization, Harmonized Tripartite Guideline, Validation of Analytical Procedures, Text and Methodology, Q2 (R1), November; 2005.
4. Maithani M, Singh R. Development and validation of a stability-indicating HPLC method for the simultaneous determination of salbutamol sulphate and theophylline in pharmaceutical dosage forms. J Anal Bioanal Techniques 2011;1:11.
5. Venkatesh V, Prabahar E, Suresh PV, Umamaheswari CH, Rama NR. A new RP-HPLC method for simultaneous estimation of etophylline and theophylline in tablets. Res J Pharm Tech 2011;4:128-30.
6. Chitlange S, Pandkar S, Tawar M, Wankhede S. Simultaneous spectrophotometric estimation of salbutamol sulphate and ambroxol hydrochloride by using various solvent in bulk as well as in tablet formulation. Asian J Res Chem 2011;4:746-9.
7. Susmitha K, Thirumalachary M, Venkateshwarlu G. Spectrophotometric determination of bromhexine HCl in pure and pharmaceutical forms. ISRN Anal Chem 2013;2013:7.
8. Chitlange SS, Chaturvedi KK, Tawargeri SR, Wankhede SB. UV spectroscopic and Stability-indicating TLC-densitometric method for simultaneous estimation of salbutamol sulphate and prednisolone in pharmaceutical dosage form. Asian J Res Chem 2011;4:786-90.
9. Prusty A, Chennupati SV, Sathpathy J. UV-Visible spectrophotometric method development and validation of assay for Etofylline tablet formulation. J Appl Chem 2014;3:2020-8.
10. Al-Ward HS. Spectrophotometric method for the determination of bromhexine hydrochloride in pure and pharmaceutical preparations. Iraqi J Sci 2011;52:400-7.
11. Jain V, Sharma MC. Validated RP-HPLC method for determining the levels of bromhexine HCl, chlorpheniramine maleate, dextromethorphan HBr and guaiphenesin in their pharmaceutical dosage forms. J Taibah Univ Sci 2016;10:38-45.
12. Gandhi SV, Mittal PS, Gaikwad AM. Development and validation of stability indicating rp-hplc method for simultaneous estimation of beclomethasonedipropionate and salbutamol sulphate. Int J Pharm Pharm Sci 2015;7:252-7.
13. Deosarkar AV, Deshpande SD, Walode SG, Tuljapure DS, Tekale SG, Waghmode VM. Simultaneous quantification of salbutamol sulphate and ambroxol hydrochloride by rp-hplc and hptlc in bulk drug and dosage form. Int J Pharm Pharm Sci 2012;4:217-21.
14. Chitlange SS, Chaturvedi KK, Wankhede SB. Development and validation of spectrophotometric and HPLC method for the simultaneous estimation of salbutamol sulphate and prednisolone in tablet dosage form. J Anal Bioanal Tech 2011;2:2.
Statistics
299 Views | 399 Downloads
Citatons
How to Cite
Rao, N., and K. D. Gawde. “METHOD DEVELOPMENT AND FORCE DEGRADATION STUDIES FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULFATE, ETOFYLLINE AND BROMHEXINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 11, no. 8, Aug. 2018, pp. 378-82, doi:10.22159/ajpcr.2018.v11i8.26119.
Section
Original Article(s)