Journal of Advanced Pharmacy Education & Research
 
 
Year : 2014   |  Volume : 4   |  Issue : 2   |  Page : 178-185  

RPHPLC method for simultaneous estimation of Ambroxol hydrochloride, Potassium clavulanate and Amoxicillin trihydrate in bulk drugs and laboratory synthetic mixture

Sadhana Rajput, Prachi Bhamre, Satish Bambhrolia

Correspondence Address:Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, G. H. Patel Building, Donor’s Plaza, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara – 390 002, Gujarat, India.

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2231-4040.197331

Abstract  

A simple, accurate, precise, specific, economical and fast gradient HPLC-PDA method has been developed and validated for the simultaneous determination of Ambroxol hydrochloride (AML), Potassium clavulanate (PC) and Amoxicillin trihydrate (AMX) in bulk drugs and laboratory prepared synthetic mixture. Effective chromatographic separation was achieved on a Phenomenex Luna C18 (250 mm×4 mm i.d., 5µm particle size) column with gradient elution of mobile phase solvent A (methanol: 0.01 M phosphate buffer (pH 3.0) (14:86)), and solvent B (methanol) and at a detection wavelength of 220 for PC, AMX and AML. The retention times for PC, AMX, and AML were 4.26, 5.15 and 6.25 min respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to linearity, range, precision, accuracy, specificity, robustness, detection limit and quantification limit as per ICH guideline Q(2). The validated HPLC method was applied to the analysis of synthetic mixture of three drugs prepared in laboratory in which the analytes were successfully quantified with good recovery values and no interfering peaks were encountered from the excipients.

Keywords: : Gradient, HPLC, Ambroxol HCl (AML), Potassium clavulanate (PC), Amoxicillin trihydrate (AMX)

How to cite this article:
: Sadhana Rajput*, Prachi

Introduction   Top

Materials and methods   Top

Results Discussion   Top

Conclusion   Top

Acknowledgement   Top

References   Top

Figures