DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULPHATE, AMBROXOL HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE IN COMBINED PHARMACEUTICAL TABLET FORMULATION: A NOVEL TECHNIQUE FOR IN-VITRO DISSOLUTION STUDIES
Keywords:
Salbutamol Sulphate, Ambroxol Hydrochloride, Cetirizine Hydrochloride, Simultaneous equation, Absorbtivity, Absorbance, Absorption Maxima, ICH guidelines, ValidationAbstract
Objective: To develop a simple, rapid, accurate, precise and economical spectroscopic method for the simultaneous determination of Salbutamol Sulphate, Ambroxol Hydrochloride and Cetirizine Hydrochloride in combined pharmaceutical tablet formulation and validate as per ICH guidelines.
Methods: In this method, the 6.8 pH phosphate buffer was selected for the developing spectral characteristics of the three drugs. The overlay spectra of Salbutamol Sulphate, Ambroxol hydrochloride and Cetirizine hydrochloride were resolved by making the use of simultaneous equation method based on measurement of absorbance at three wavelengths.
Results: The λmax of Salbutamol Sulphate, Ambroxol Hydrochloride and Cetirizine hydrochloride were found to be 276 nm, 244 nm and 230 nm. The method obeyed Beer Lambert's law in the concentration range of 10-100 µg/ml for SAL, 2- 18 µg/ml for AMB HCl and 2-20 µg/ml for CET HCl. The high values of correlation coefficient (R) indicated good linearity of calibration plot for the drugs. Result of percentage recovery study confirms the accuracy of proposed method. Percentage RSD for precision and accuracy of the method was found to be less than 2%. LOD values for SAL, AMB, and CET were found to be 0.523 ðœ‡g/mL, 0.450 ðœ‡g/mL and 0.457 ðœ‡g/mL, respectively. LOQ values for SAL, AMB, and CET were found to be 1.372 ðœ‡g/mL, 1.424 ðœ‡g/mL and 1.386 ðœ‡g/mL, respectively.
Conclusion: A rapid, economical, accurate, precise and reproducible simultaneous equation spectroscopic method was developed and validated. The proposed method can be employed for routine analysis of Salbutamol Sulphate, Ambroxol Hydrochloride and Cetirizine Hydrochloride in combined pharmaceutical tablet formulation.
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References
Indian Pharmacopoeia. Vol-III. Ministry of Health and Family Welfare. Published by Indian Pharmacopoeia Commission; 2007. p. 1063-64.
British Pharmacopeia. Vol-. I, II. Published by British Pharmacopoeia Commission; 2009. p. 5345-9.
Nayak S, Das B, Tarai DK, Panda D, Sahoo J. Formulation and evaluation of salbutamol sulphate fast dissolving tablet. J Pharm Res 2010;3(4):824-7.
Indian Pharmacopoeia. Vol-III. Ministry of Health and Family Welfare. J Published by Indian Pharmacopoeia Commission; 2007. p. 83.
British Pharmacopeia. Vol-. I, II. Published by British Pharmacopoeia Commission; 2009. p. 265-8.
Tripathi KD. Essential of Medical Pharmacology. 6th ed. Jaypee Brothers Medical Publisher (P) LTD; 2008. p. 214.
Indian Pharmacopoeia. Vol-III. Ministry of Health and Family Welfare. J Published by Indian Pharmacopoeia Commission; 2007. p. 274-5.
British Pharmacopeia. Vol-. I, II. Published by British Pharmacopoeia Commission; 2009. p. 1198-202.
Tripathi KD. Essential of Medical Pharmacology. 6th ed. Jaypee Brothers Medical Publisher (P) LTD; 2008. p. 159.
Rele RV, Gurav PJ. Simple Spectrophotometric methods for determination of Ambroxol Hydrochloride from pharmaceutical formulation. Int J Pharm Tech Res 2012;4(3): 994-8.
Panda SS, Kumar BVVR, Mohanta G. Difference UV spectrophotometric method for estimation of Levosalbutamol sulphate in tablet dosage form. J Pharm Edu Res 2012;3(1):17-21.
Wankhede SB, Lad KA, Chitlange SS. Development and validation of UV-spectrophotometric methods for simultaneous estimation of cetirizine hydrochloride and phenylephrine hydrochloride in tablets. Int J Pharm Sci Drug Res 2010;4(3):222-6.
Sharma D, Kumar D, Singh M, Singh G. Spectrophotometric method development and validation for simultaneous estimation of Salbutamol Sulphate and Ambroxol Hydrochloride in combined dosage forms. Int J Drug Dev Res 2013;5(4): 124-32.
Ponnilavarasan I, Narendra CS, Asha P. Simultaneous estimation of Ambroxol Hydrochloride and Loratadine in tablet dosage form by using UV spectrophotometric method. Int J Pharm Bio Sci 2011;2(2):338–44.
Prabu S, Shirwaikar A, Kumar C, Kumar G. Simultaneous UV spectrophotometric estimation of Ambroxol Hydrochloride and Levocetirizine Dihydrochloride. Indian J Pharm Sci 2008;70(2): 236-8.
Sharma D, Kumar D, Singh M, Singh G. Development and Validation of spectrophotometric method for simultaneous estimation of salbutamol sulphate and cetirizine hydrochloride in combined dosage forms. Int Res J Pharm 2012;3(7):293-6.
Prathap B, Nagarajan G, Dinakar A, Rao GS, Singh R, Rathor B, et al. Spectrophotometric method for simultaneous estimation of Gatifloxacin and Ambroxol Hydrochloride in tablet dosage form. Der Pharm Lett 2011;3(3): 62-8.
Patel PA, Dole MN, Shedpure PS, Sawant SD. Spectrophotometric simultaneous estimation of Salbutamol and Ambroxol in bulk and formulation. Asian J Pharm Clin Res 2011;4(3):42-5.
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. p. 1-8.
Abirami G, Vetrichelvan T, Bhavyasri M. Development and Validation of UV spectroscopy method for the determination of cefpodoxime proxetil and ambroxol hydrochloride in pharmaceutical formulation. Int J Pharm Tech Res 2012;4(2): 623-9.
Sharma D, Singh M, Kumar D, Singh G. Simultaneous estimation of ambroxol hydrochloride and cetirizine hydrochloride in pharmaceutical tablet dosage form by simultaneous equation spectrophotometric method: a quality control tool for dissolution studies. ISRN Anal Chem 2014:1-6.
Arun MP, Rahul BG. Development and validation of RP-HPLC method for simultaneous determination of Ambroxol Hydrochloride, Levocetirizine Dihydrochloride and Phenylephrine Hydrochloride in combined dosage form. Inventi Rapid: Pharmaceutical Analysis & Quality Assurance; 2013.
Gopalakrishnan S, Chitra TA, Aruna A, Chenthilnathan A. Development of RP-HPLC method for the simultaneous estimation of Ambroxol Hydrochloride, Cetirizine Hydrochloride and antimicrobial preservatives in combined dosage form. Der Pharm Chem 2012;4(3):1003-15.
Goswami J, Kakadiya J, Shah N. RP-HPLC method development and validation for simultaneous estimation of Ambroxol Hydrochloride and Cefpodoxime Proxetile in pharmaceutical dosage form. Am J Pharmatech Res 2012;2:1043-52
Maithani M, Raturi R, Gautam V, Kumar D, Gaurav A, Singh R. Simultaneous estimation of ambroxol hydrochloride and cetirizine hydrochloride in tablet dosage form by RP-HPLC Method. Intl J Comp Pharm 2010;2(3):1-3.
Kumar TP, Haque MA, Kumar KP, Nivedita G, Diwan VP. Simultaneous determination of cetirizine hydrochloride and ambroxol hydrochloride in combined dosage form by using RP-HPLC Method. Amer J Pharm Tech Res 2012;2(6):716-23.
Raja MG, Geetha G, Sankaranarayanan A, Raju KMG, Kumar PS. Simultaneous and Stability indicating method for determination of Cetrizine hydrochloride and Ambroxol hydrochloride in syrup. Int J Pharm Sci Res 2012;3(8):2658-63.
Bhatia NM, Ganbavale SK, Bhatia MS, More HN. RP-HPLC and spectrophotometric estimation of ambroxol hydrochloride and cetirizine hydrochloride in combined dosage form. Indian J Pharm Sci 2008;70(5):603-08.
Venkateshwari P, Kumar GVS, Puranik SB, Srinivas S, Reddy R, Ramya G, Sridhar KA. Development of Stability Indicating RP-HPLC method for simultaneous estimation of Ambroxol hydrochloride and Levocetirizine dihydrochloride. Int J Adv Pharm Anal 2012;2(2):34-40.
Urwashi DR, Wate SP. RP-HPLC method development and validation for simultaneous estimation of Levocetirizne Dihydrochloride and Phenylephrine Hydrochloride in their tablet dosage form. Asian J Res Chem 2013;6:1-3.
Arora P, Arora V, Jain S. Simultaneous estimation of Cetirizine Dihydrochloride and Ambroxol Hydrochloride in pharmaceutical formulation by a novel HPLC method. Int J Pharm Sci Res 2012;2(12):3149-51.
Suryan AL, Bhusari VK, Rasal KS, Dhaneshwar SR. Simultaneous quantitation and validation of Paracetamol, Phenylpropanolamine Hydrochloride and Cetirizine Hydrochloride by RP-HPLC in bulk drug and formulation. Int J Pharm Sci Drug Res 2011;3(4):303-08.
Suresh R, Manavalan R, Valliappan K. HPLC method for the simultaneous determination of levocetirizine, Ambroxol and montelukast in human plasma employing response surface methodology. Int J Drug Dev Res 2012;4(3):173-85.
Trivedi RK, Patel MC, Jadhav SB. A rapid, stability indicating RP-UPLC method for simultaneous determination of Ambroxol Hydrochloride, Cetirizine Hydrochloride and antimicrobial preservatives in liquid pharmaceutical formulation. Sci Pharm 2011;79(3):525-43.
Patel BA, Patel SG, Patel DP, Patel BH, Patel MM. Stability indicating HPTLC method development and validation for estimation of Ambroxol Hydrochloride and Cetirizine Dihydrochloride in combine tablet dosage form. Int Res J Pharm 2011;2(3):95–9.
Raja T, Rao AL. Development and validation of HPTLC method for the simultaneous estimation of Gemifloxacin Mesylate and Ambroxol Hydrochloride in bulk and tablet dosage form. Anal Chem Lett 2013;2(3):152-8.
Rathore AS, Sathiyanarayanan L, Mahadik KR. Development of validated HPLC and HPTLC methods for simultaneous determination of Levocetirizine Dihydrochloride and Montelukast Sodium in bulk drug and pharmaceutical dosage form. J Pharm Anal Acta 2010;1(1):1-6.
Kim H, Yoo JY, Han SB, Lee HJ, Lee KR. Determination of Ambroxol in human plasma using LC-MS/MS. J Pharm Biomed Anal 2003;32(2):209-16.
ICH Tripartite Guidelines, Q2R1 Validation of Analytical Procedures: Text and Methodology, ICH, Geneva, Switzerland; 2005.
ICH Tripartite Guidelines, Q2B Validation of Analytical Procedures: Text and Methodology, ICH, Geneva, Switzerland; 1996.