Author(s): Dipon Roy, Priyanka Chandra, Manik Ghosh, Arup Mondal, Pankaj Dagur, Mayur A. Patel, Sanjit Mandal, Rajiv Jash, Robina Khatun, Suddhasattya Dey

Email(s): kuntal.kuni@gmail.com , khatunrobina95@gmail.com

DOI: 10.52711/0974-360X.2023.00743   

Address: Dipon Roy1, Priyanka Chandra1, Manik Ghosh1, Arup Mondal1, Pankaj Dagur1, Mayur A. Patel2, Sanjit Mandal3, Rajiv Jash4, Robina Khatun4*, Suddhasattya Dey5*
1Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, India.
2Sigma Institute of Pharmacy, Bakrol, Vadodara, Gujrat, India.
3Bengal College of Pharmaceutical Sciences and Research, Durgapur, West Bengal 713206, India.
4Department of Pharmacy, Sanaka Educational Trust`s Group of Institutions, West Bengal 713212, India.
5Bengal College of Pharmaceutical Technology College, Dubrajpur, West Bengal 731123, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 10,     Year - 2023


ABSTRACT:
A simple, rapid, sensitive and new RP-HPLC method was developed and validated concerning ICH guidelines for simultaneous assessment of doxylamine succinate (DOXY) and pyridoxine hydrochloride (PYRI) in bulk and combined dosage form. Isolation was performed on C18 column, using phosphate buffer (pH 4.0) and acetonitrile (70:30) as mobile phase, flow rate at 1ml/min. Retention times were 4.256 min and 2.400 min for DOXY and PYRI respectively. Linearity for both drugs were in the concentration range of 10-50µg/ml. Correlation coefficients were 0.999 and 0.999 for DOXY and PYRI respectively. Method was validated according to the parameters of ICH guidelines.The accelerated stability study was conducted as per the ICH guidelines. Study suggests that both the drugs were most stable in photolytic condition. DOXY was more susceptible in basic condition whereas in oxidation condition PYRI was more susceptible. Results obtained were quite satisfactory for this method and this method can be suitable for the estimation of DOXY and PYRI in any formulation along with degradation product.


Cite this article:
Dipon Roy, Priyanka Chandra, Manik Ghosh, Arup Mondal, Pankaj Dagur, Mayur A. Patel, Sanjit Mandal, Rajiv Jash, Robina Khatun, Suddhasattya Dey. A Stability Indicating Assay Method for the Simultaneous Estimation of Doxylamine Succinate and Pyridoxine Hydrochloride in Bulk and Combined Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(10):4559-7. doi: 10.52711/0974-360X.2023.00743

Cite(Electronic):
Dipon Roy, Priyanka Chandra, Manik Ghosh, Arup Mondal, Pankaj Dagur, Mayur A. Patel, Sanjit Mandal, Rajiv Jash, Robina Khatun, Suddhasattya Dey. A Stability Indicating Assay Method for the Simultaneous Estimation of Doxylamine Succinate and Pyridoxine Hydrochloride in Bulk and Combined Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(10):4559-7. doi: 10.52711/0974-360X.2023.00743   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-10-13


REFERENCES:
1.    Jin P. Xia L. Li Z. Che N. Zou D. Hu X. Rapid determination of thiamine, riboflavin, niacinamide, pantothenic acid, pyridoxine, folic acid and ascorbic acid in vitamins with minerals tablets by high-performance liquid chromatography with diode array detector. J. Pharm. Biomed. Anal. 2012; 1(70):151-7.doi.org/10.1016/j.jpba.2012.06.020
2.    Nuangchamnong N. Niebyl J. Doxylamine succinate–pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview. Int J Womens Health. 2014; 6: 401. doi.10.2147/IJWH.S46653.
3.    Badell ML. Ramin SM. Smith JA. Treatment options for nausea and vomiting during pregnancy. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2006; 26(9):1273-87. doi.org/10.1592/phco.26.9.1273.
4.    Harde MT. Lakade SH. A stability-indicating HPLC method for estimation of doxylamine succinate in tablets and characterization of its major alkaline stress degradation product. Future J. Pharm. Sci. 2021; 7(1):1-3. doi.org/10.1186/s43094-021-00276-6
5.    Habib NM. Abdelwhab NS. Abdelrahman MM.Ali NW. Spectrophotometric methods for analysis of different dosage forms containing pyridoxine hydrochloride. Eur. J. Chem. 2016; 7(1):30-6. doi.org/10.5155/eurjchem.7.1.30-36.1350
6.    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. doi.10.4103/0250-474X.44607
7.    Uslu B. Özkan SA. Aboul-Enein HY. Spectrophotometric determination of melatonin and pyridoxine HCL in binary mixture using first derivative of the ratio spectra method. Anal. Lett. 2002; 35(14):2305-17. doi.org/10.1081/AL-120016104
8.    Bhamre PR. Pathak AS. Rajput S. Simultaneous determination of doxylamine succinate, pyridoxine hydrochloride and folic acid by chemometric spectrophotometry. Int. J. Pharm. Sci. 2013; 4(1):738-49.doi.10.4103/0250-474x.44607
9.    Consigliere VO. Vals NR. Magalhãs JF. First-derivative spectrophotometric determination of pyridoxine hydrochloride in pharmaceutical preparations. Anal. Lett. 2001; 34(11):1875-88. doi.org/10.1081/AL-100106118
10.    Malothu N. Areti AR. Araja S. Paidi M. Swathi S. Chamala VD. Srivani NN. 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):4613-20. doi.10.5958/0974-360x.2020.00812.4
11.    Wate SP. Bhagwat GB. Mundhey AS. Bawankar PM. Absorption Ratio Method for Simultaneous Estimation of Prochlorperazine Maleate and Pyridoxine Hydrochloride in Tablet. Research J. Pharm. and Tech. 2012; 5(8):1112-3.doi.10.5958/0974-360x.
12.    Ibrahim MM. Elzanfaly ES. El-Zeiny MB. Ramadan NK. Kelani KM. Spectrophotometric determination of meclizine hydrochloride and pyridoxine hydrochloride in laboratory prepared mixtures and in their pharmaceutical preparation. Spectrochimica Acta Part A: Spectrochim Acta A Mol Biomol Spectrosc. 2017; 178:234-8. doi.org/10.1016/j.saa.2017.02.013
13.    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.doi.org/10.4103%2F0250-474X.44607
14.    R. E. Tarigan. S. M. Sinaga. Muchlisyam. Z. Alfian.Simultaneous Determination of Dextromethorphan Hydrobromide, Doxylamine Succinate And Pseudoephedrine Hydrochloride In Cough And Cold Syrup By Area Under Curve Spectrophotometry Method. Rasayan J. Chem. 2021; 14(1): 629-634. doi.org/10.31788/ RJC.2021.1416068
15.    Argekar AP, Sawant JG. Simultaneous determination of pyridoxine hydrochloride and doxylamine succinate in tablets by HPTLC. J. Liq. Chromatogr. Relat. 1999;  22(13): 2051-60. doi.org/10.1081/JLC-100101785
16.    Giriraj P. Sivakkumar 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; 2014. doi.10.1155/2014/827895
17.    Nawaz M. A new validated stability indicating RP-HPLC method for simultaneous estimation of pyridoxine hydrochloride and meclizine hydrochloride in pharmaceutical solid dosage forms. Chromatogr. Res. Int. 2013; 2013.doi.org/10.1155/2013/747060
18.    Gil-Agustí M. Capella-Peiró ME. Monferrer-Pons L. García-Alvarez-Coque MC. Esteve-Romero J. Chromatographic analysis of phenethylamine–antihistamine combinations using C8, C18 or cyano columns and micellar sodium dodecyl sulfate–pentanol mixtures. Analyst. 2001; 126(4):457-64. doi.org/10.1039/b009546j
19.    Almakaiev MS. Dvinskikh NV. Almakaieva LG. Kryvanych OV. Development of a combined solution of pyrimidine nucleotides with vitamin B6. Research J. Pharm. and Tech. 2021; 14(12):6228-34.doi.10.52711/0974-360x.2021.01078  
20.    Bhagwat GB. Jaybhaye M. Development and Validation of a RP-HPLC Method for the Simultaneous Estimation of Prochlorperazine Maleate and Pyridoxine Hydrochloride in Combined Dosage Forms. Research J. Pharm. and Tech. 2018; 11(4):1338-42. doi.10.5958/0974-360x.2018.00249.4
21.    Nagappan KV. Meyyanathan SN. Raja RB, Reddy S. Jeyaprakash MR. Birajdar AS. Bhojraj S. A RP-HPLC method for Simultaneous Estimation of Ambroxol Hydrochloride and Loratidine in pharmaceutical formulation. Research J. Pharm. and Tech. 2008; 1(4):366-9.doi.10.5958/0974-360x.
22.    Thorat Shashikant D. Ghodeswar B. C. Darode G. S. Shinde N. S. Chaudhari S. R. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Cholecalcererol (Vitamin D3) and Tocopherol Acetate (Vitamin E) in Powder Dosage Form. Research J. Pharm. and Tech. 2013; 6(10): 1107-1110. doi.10.5958/0974-360x.
23.    Sulthoniyah D. Primaharinastiti R. Annuryanti F. Method validation of flame atomic absorption spectrophotometry (FAAS) for determination of iron (FE) in multivitamin mineral capsule dosage form. Research J. Pharm. and Tech. 2018; 11(6): 2569-74.doi.10.5958/0974-360x.2018.00475.4
24.    Nalini CN. Method Development and Validation for the Simultaneous Estimation of Ascorbic acid, Phenylephrine HCl, Paracetamol and Levocetirizine HCl using RP-HPLC. Research J. Pharm. and Tech. 2020; 13(4):1911-6.doi.10.5958/0974-360x.2020.00344.3
25.    Das P. Prabhu PP. Reddy J. Development and Validated Stability indicating RP-HPLC method for quantitative determination of Ascorbic acid and piperine in Dhathryaristam. Research J. Pharm. and Tech. 2020; 13(8): 3729-32. doi.10.5958/0974-360x.2020.00660.5
26.    Choudhari VP. Kale AN. Polshettiwar SA. Sutar AS. Patel DM. Kuchekar BS. Derivative and Absorption Factor Spectrophotometric Estimation of Montelukast Sodium and Levocetirizine Dihydrochloride from Pharmaceutical Formulations. Research J. Pharm. and Tech. 2011; 4(3):389-92. doi.10.5958/0974-360x.
27.    Bitar Y. Separation and assay of three anti-cough drugs pseudoephedrine, dextromethorphan and chlorpheniramine in pharmaceutical forms by using single RP-HPLC METHOD. Research J. Pharm. and Tech. 2020; 13(2):831-9.doi.10.5958/0974-360x.2020.00157.2.
28.    Singh SK. Validation of isocratic RP-HPLC method and UV spectrophotometric method for the estimation of loratadine in pharmaceutical formulations. Research J. Pharm. and Tech. 2015; 8(4):452-61. doi.10.5958/0974-360x.2015.00076.1
29.    Polawar PV. Shivhare UD. Bhusari KP. Mathur VB. Development and validation of spectrophotometric method of analysis for fexofenadine HCl. Research J. Pharm. and Tech. 2008; 1(4):539-40. doi.10.5958/0974-360x.
30.    Guideline ICH. Validation of analytical procedures: text and methodology. Q2 (R1). 2005;1(20):05.
31.    Guideline, ICH Harmonised Tripartite. Stability testing of new drug substances and products. Q1A (R2), current step 4 (2003): 1-24.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available