STABILITY INDICATING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE, PARACETAMOL, GUAIPHENESIN AND BROMHEXINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATION
Objective: The objective of the present study is to develop simple, rapid, sensitive, accurate and economic stability-indicating ultra-performance liquid chromatographic (UPLC) method for the simultaneous quantification of phenylephrine hydrochloride, chlorpheniramine maleate, paracetamol, guaiphenesin and bromhexine hydrochloride in bulk and tablet dosage form.
Methods: The separation of drugs in the chromatographic column was accomplished on Hibar C18 (100 mm x 2.1 mm, 1.6 µm) column at a detection wavelength of 220 nm. The mobile phase was a combination of sodium phosphate monobasic monohydrate buffer (pH was adjusted to 3.5 with orthophosphoric acid) and acetonitrile in the ratio of 70:30 % v/v which was pumped at a flow rate of 0.3 ml/min. The column temperature was maintained at 30 °C and the injection volume was 0.3 µl. Forced degradation studies of drugs were carried out using acid, base, peroxide, light and heat.
Results: All the five drugs have been eluted within 3 min. The retention times were found to be 0.834 min, 1.199 min, 1.600 min, 1.979 min and 2.525 min for phenylephrine, chlorpheniramine maleate, paracetamol, guaiphenesin and bromhexine respectively. The correlation coefficient (r2) was found to be 0.999 for all the drugs. The recovery levels were found to be in the range of 99.17 % to 100.69 %. RSD values of drugs were found to be below 2 %. The results of limit of detection and quantitation specified the sensitivity of the developed method. Significant degradation of drugs as a result of stress studies was found in acid, base and peroxide, but they were slightly degraded in photolytic and thermal conditions. The method has effectively resolved the degraded products. All the validation parameters were found to be within the limits according to International Conference on Harmonization (ICH) guidelines.
Conclusion: A simple and rapid UPLC method was established for the determination of five drugs. Hence, the proposed method can be employed for the quality control of specified drugs in bulk and pharmaceutical formulation even in the presence of degradation products.
2. Blessy S, Prasanthi C, Parameswari S, Aruna G. A novel HPLC method for the simultaneous determination of chlorpheniramine maleate and dextromethorphan in bulk and pharmaceutical formulation. Int J Pharm Sci Res 2018;9:1147-51.
3. Magesh AR, Dhanaraju MD. Development and validation of RP-HPLC method for simultaneous estimation of diethylcarbamazine citrate and chlorpheniramine maleate in pharmaceutical preparations. Chem Sci Trans 2017;6:316-22.
4. Satyanarayanamurthy R, Hanimireddy B, Maramravikumar B, Joy sunandan B. RP-HPLC method development and validation for quantification of paracetamol and ibuprofen and its related impurities in the solid dosage form. Int J Pharma Bio Sci 2017;8:152-68.
5. Neelima G, Sreerama R, Prasanth Kumar T, Immanuel A, Prayas A. Development and validation of RP-HPLC method for simultaneous estimation of guaifenesin and pseudoephedrine HCl in extended-release tablet dosage form. Der Pharm Chem 2017;9:43-7.
6. Kapildev RJ. Analytical method development and validation of RP-HPLC for simultaneous estimation of chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride in cough syrup. Int J Adv Sci Eng Inf Technol 2016;4:35-9.
7. Jivani N, Hitesh V, Hetal P. Stability indicating HPLC method development and validation for simultaneous estimation of bromhexine and phenylephrine HCl in its combined pharmaceutical dosage form. J Pharm Sci Biosci Res 2016;6:523-8.
8. Vanita D, Jinal T, Paya C, Samir S. A novel stability-indicating RP-HPLC method development and validation for estimation of phenylephrine hydrochloride and bromhexine hydrochloride in their tablet dosage form. Int J Curr Pharm Res 2016;6:1839-51.
9. Vijay Kumar R, Vinay UR. A novel stability-indicating RP-HPLC method development and validation for simultaneous estimation of phenylephrine, acetaminophen, guaifenesin and dextromethorphan in the tablet dosage form. Pharm Lett 2015;7:329-39.
10. Ali A, Ahmed M, Mahmud T, Qadir MA, Nadeem K, Saleem A. Stability is indicating high-performance liquid chromatography method for simultaneous determination of aminophylline and chlorpheniramine maleate in pharmaceutical formulations. Indian J Pharm Sci 2015;77:515-21.
11. Allabasha M, Iffath R. Simultaneous estimation of paracetamol, ibuprofen and famotidine by using RP-HPLC method. Indo Am J Pharm Res 2015;5:2965-80.
12. Ankit B, Shweta MB, Chintal MS. Development and validation of RP-HPLC method for simultaneous estimation of bromhexine hydrochloride, guaiphenesin and chlorpheniramine maleate in tablet. World J Pharm Pharm Sci 2015;4:1679-94.
13. Rani S, Ritu M, Satish Y. Liquid chromatography-tandem mass spectrometry method development and validation for the simultaneous analysis of paracetamol, guaifenesin, phenylephrine hydrochloride, chlorpheniramine maleate, and ambroxol hydrochloride in bulk and in tablet dosage form. Asian J Pharm Clin Res 2018;11:375-82.
14. Fitria A, Muchlisyam B, Siti Morin S. Development and validation of double divisor ratio spectra derivative spectrophotometry method for a ternary mixture of guaifenesin, dextromethorphan HBr, and diphenhydramine HCl in tablet dosage form. Asian J Pharm Clin Res 2018;11:1-3.
15. Nalini K, Narmada P, Vijay Lakshmi G, Yogi K. Simultaneous estimation of paracetamol, guaiphensin, phenylephrine HCl, chlorpheniramine maleate, bromhexine HCl in combined tablet dosage form by RP-HPLC. Int J Pharm Sci Res 2014;5:410-6.
16. International conference on harmonization tripartite guideline on validation of analytical procedures text and methodology: Q2 (R1); 2005.
This work is licensed under a Creative Commons Attribution 4.0 International License.