Narender Malothu, Anka Rao Areti, Sreehasa Araja, Mounika Paidi, Sonekar Swathi, Vijaya Durga Chamala, Navya Srivani N
Narender Malothu1*, Anka Rao Areti1, Sreehasa Araja2, Mounika Paidi 2, Sonekar Swathi 2, Vijaya Durga Chamala2, Navya Srivani N2
1KL College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram, Guntur, AP, India.
2Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada, India.
Volume - 13,
Issue - 10,
Year - 2020
Simple and precise UV-spectrophotometric methods were developed and validated for the simultaneous estimation of combined dosage form containing Doxylamine succinate and Pyridoxine HCl. A combination of these drugs is being used in the treatment of morning sickness associated with pregnancy. In the current study, both the drugs estimated by simultaneous equation and Q-absorbance ratio methods with the help of 260 and 290 nm as maximum absorption wavelengths, respectively for Doxylamine succinate and Pyridoxine HCl. Linearity was achieved at the concentration of 10-35 µg/mL for both drugs with correlation coefficient (r2) of 0.9949 and 0.9935, respectively. The % RSD for accuracy and precision were lies within the acceptance criteria. The percentage (%) recoveries found for both drugs were in the potency range (98.14-100.5 %). There was good agreement in results obtained for detection and quantitation limits studies which revealed the presence of sensitivity of the methods. The assay of the commercial sample was in well fit with the standards and the developed methods can allow for usual analysis of both drugs in combined dosage forms.
Cite this article:
Narender Malothu, Anka Rao Areti, Sreehasa Araja, Mounika Paidi, Sonekar Swathi, Vijaya Durga Chamala, Navya Srivani N. UV-Spectroscopic Method development and Validation for simultaneous estimation of Doxylamine succinate and Pyridoxine hydrochloride in bulk and Pharmaceutical dosage form. Research J. Pharm. and Tech. 2020; 13(10):4613-4620. doi: 10.5958/0974-360X.2020.00812.4
Narender Malothu, Anka Rao Areti, Sreehasa Araja, Mounika Paidi, Sonekar Swathi, Vijaya Durga Chamala, Navya Srivani N. UV-Spectroscopic Method development and Validation for simultaneous estimation of Doxylamine succinate and Pyridoxine hydrochloride in bulk and Pharmaceutical dosage form. Research J. Pharm. and Tech. 2020; 13(10):4613-4620. doi: 10.5958/0974-360X.2020.00812.4 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-10-15
1. Pathak A, Rajput SJ. Simultaneous derivative spectrophotometric analysis of doxylamine succinate, pyridoxine hydrochloride and folic acid in combined dosage forms. Indian J Pharm Sci. 2008; 70(4): 513-517.
2. Nayak SC, Kulkarni PV, Bhaskar V, Chavhan V. Development and validation of UV spectrophotometric method for simultaneous estimation of doxylamine succinate and pyridoxine hydrochloride in bulk and tablet dosage form. Int J Pharm Pharm Sci. 2013; 5(3): 390-393.
3. Secker VR, Baig IS, Amulya R, Nagarjuna P. A validated simultaneous estimation of doxylamine succinate and pyridoxine hydrochloride by UV-spectrophotometric method in bulk and formulation. Int J Pharmaceut Anal. 2014; 4(2): 139-143.
4. Katsarov P, Gergov G, Alin A, Pilicheva B, Al-Degs Y, Simeonov V, Kassarova M. Advanced spectrophotometric chemometric methods for resolving the binary mixture of doxylamine succinate and pyridoxine hydrochloride. Acta Pharm. 2018; 68: 61-73.
5. Argekar AP, Sawant JG. Simultaneous determination of pyridoxine hydrochloride and doxylamine succinate from tablets by ion pair reversed-phase high-performance liquid chromatography (RP-HPLC). Drug Dev Ind Pharm. 1999; 25(8): 945-950.
6. Ozkirimli S, Aboul-Enein HY, Cesur N. Enantioselective quantification of doxylamine in human plasma by HPLC. J Liq Chromatogr Relat Technol. 2011; 34: 671-678.
7. Donato JL, Koizumi F, Pereira AS, Mendes GD, DeNucci G. Simultaneous determination of dextromethorphan, dextrorphan and doxylamine in human plasma by HPLC coupled to electrospray ionization tandem mass spectrometry: Application to a pharmacokinetic study. J. Chromatogr B. 2012; 899: 46-56.
8. Rosa PCP, Jardim ICSF. Simultaneous determination of clobutinol hydrochloride and doxylamine succinate from syrups by RP HPLC using a new stationary phase containing embedded urea polar groups. Braz J Pharm Sci. 2012; 48(2): 315-324.
9. Raja A, Samatha M, Banji MD, Rao KNV, Sujitha, Vinod J, Kumar DS. Analytical method development and validation of acetamenophen dextromethorphan hydro bromide doxylamine succinate in soft gel capsule dosage form by using RP-HPLC. World J Pharm Pharm Sci. 2013; 2(6): 5852-5862.
10. Giriraj P, Sivakkmarb T. Development and validation of a rapid chemometrics assisted RP-HPLC with PDA detection method for the simultaneous estimation of pyridoxine hcl and doxylamine succinate in bulk and pharmaceutical dosage form. Chromatogr Res Int. 2014; 1-9.
11. Bortake P, Lokhande RS. Analytical method development and validation of acetaminophen, doxylamine succinate and dextromethorphan hydrobromide in liquicap dosage form by RP-HPLC. Int J Pharm Sci Invent. 2014; 3(7): 08-12.
12. Krishna VR, Veni PRK, Vijay K, Krishna KBM, Babu BH. Development and validation of liquid chromatographic method for the simultaneous estimation of doxylamine succinate, pyridoxine hydrochloride and folic acid in the combined dosage form. World J Pharm Pharm Sci. 2014; 3(3): 1283-1298.
13. Varasala D, Konidela SK. Stability-indicating RP-HPLC method development and validation for simultaneous determination of doxylamine succinate and dextromethorphan hydrobromide in pharmaceutical dosage forms. Der Pharmacin Lettre. 2015; 7(2): 112-118.
14. Mohan B, Rao BK, Rao SVMM, Venugopal NVS. Related substances of acetaminophen in acetaminophen, dextromethorphan HBr and doxylamine succinate soft gelatin capsules by using RP-HPLC Method. Am J Pharm Tech Res. 2016; 6(6): 339-352.
15. Kumar BP, Vidyadhara S, Murthy TEGK, Sasidhar RLC, Krishna VS. Development and validation of RP-HPLC method for simultaneous estimation of doxylamine succinate and pyridoxine hydrochloride in bulk and pharmaceutical dosage forms. Eurasian J Anal Chem. 2017; 12(5): 459-468.
16. Richards MP, Kumar VK. A new RP-HPLC method develops a new RP-HPLC method development and validation for simultaneous estimation of pyridoxine hydrochloride and doxylamine succinate in bulk drug and pharmaceutical tablet dosage form. IOSR J Pharm Bio Sci. 2017; 12(5): 74-79.
17. Ravichandran S, Selvakumar S, Afreen, Banu N. RP-HPLC method development and validation for the doxylamine succinate and pyridoxine HCl in its pure and pharmaceutical tablet dosage form. Indian J Pharm Sci Res. 2018; 8(1): 35-43.
18. Nguyen K, Sherma J. Development of quantitative HPTLC–densitometry methods for the analysis of amiodarone HCl, carvedilol, doxylamine succinate, magnesium salicylate, metoprolol succinate, nebivolol HCl, and salicylamide using a model process developed earlier for the transfer of TLC screening methods. Acta Chromatographica. 2018; 30: 264-268.
19. Branscomb CJ, Holder CL, Korfmacher WA, Cerniglia CE, Rushing LG. GC/ MS characterization of urinary metabolites of doxylamine succinate: identification of the aglycones formed from intestinal microflora metabolism of the polar glucuronide metabolites. J High Resolut Chromatogr. 1988; 517-520.
20. ICH. “Q2 (R1), Validation of analytical procedures: text and methodology”, in proceedings of ICH, Geneva, Switzerland. 2005; 1.11