DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING REVERSE PHASEHIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF CLINDAMYCIN, METRONIDAZOLE, AND CLOTRIMAZOLE IN PHARMACEUTICAL COMBINED DOSAGE FORMS

Authors

  • Revathi Naga Lakshmi Ponnuri
  • Prahlad Pragallapati
  • Mastanamma Sk
  • Ravindra N
  • Venkata Basaveswara Rao Mandava
  • Borusu Sri Naga Sudha
  • Koppisetti Baladurga Prasad

DOI:

https://doi.org/10.22159/ajpcr.2017.v10i1.14273

Abstract

Objective: The objective of present work was to develop and validate a simple, fast, precise, selective, and accurate reverse phase high-performance
liquid chromatography method for the simultaneous determination of Clindamycine, Metronidazole and Clotrimazole in a pharmaceutical dosage form.

Methods: The separation of these three drugs was achieved on ODS 250×4.6 mm, 5 mm C18 column. Mobile phase containing 0.1% ortho phosphoric
acid buffer and acetonitrile in the ratio of 55:45 v/v was pumped through column at a flow rate of 1 ml/minute. Temperature was maintained at 30°C
and ultraviolet detection at 238 nm.

Results: The retention times were observed to be 2.591, 3.584, and 4.221 minutes for Clindamycine, Metronidazole, and Clotrimazole, respectively.
Linearity was found to be 25-150 μg/ml Clindamycine, Metronidazole, and Clotrimazole, respectively. The method was statistically validated for
linearity, recovery, the limit of detection (LOD), limit of quantification (LOQ), accuracy, and precision. The stress testing of the drugs individually and
their mixture are carried out under acidic, alkaline, oxidation, photostability, and thermal degradation conditions and its degradation products are
well resolved from the analyte peaks.

Conclusion: This method was successfully validated for accuracy, precision, and linearity, LOD, and LOQ.

Keywords: Clindamycine, Metronidazole, Clotrimazole, Reverse phase-high performance liquid chromatography, Simultaneous determination,
Degradation studies.

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References

Daum RS. Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. N Engl J Med 2007;357(4):380-90.

Klempner MS, Styrt B. Clindamycin uptake by human neutrophils. J Infect Dis 1981;144(5):472-9.

Li LH, Kuentzel SL, Shugars KD, Bhuyan BK. Cytotoxicity of several marketed antibiotics on mammalian cells in culture. J Antibiot (Tokyo) 1977;30(6):506-12.

Shennan A, Crawshaw S, Briley A, Hawken J, Seed P, Jones G, et al. A randomised controlled trial of metronidazole for the prevention of preterm birth in women positive for cervicovaginal fetal fibronectin: The PREMET study. BJOG 2006;113(1):65-74.

Lamont RF. Can antibiotics prevent preterm birth-the pro and con debate. BJOG 2005;112 Suppl 1:67-73.

Williams CS, Woodcock KR. Do ethanol and metronidazole interact to produce a disulfiram-like reaction? Ann Pharmacother 2000;34(2):255-7.

Visapää JP, Tillonen JS, Kaihovaara PS, Salaspuro MP. Lack of disulfiram-like reaction with metronidazole and ethanol. Ann Pharmacother 2002;36(6):971-4.

Sawyer PR, Brogden RN, Pinder RM, Speight TM, Avery. Clotrimazole: A review of its antifungal activity and therapeutic efficacy. Drugs 1975;9(6):424-47.

Jensen BS, Strøbaek D, Olesen SP, Christophersen P. The Ca2+-activated K+ channel of intermediate conductance: A molecular target for novel treatments? Curr Drug Targets 2001;2(6):401-22.

Carrillo-Muñoz AJ, Brió S, Alonso R, del Valle O, Santos P, Quindós G. Ciclopiroxolamine: In vitro antifungal activity against clinical yeast isolates. Int J Antimicrob Agents 2002;20(5):375-9.

Seethalakshmi N, Chenthilnathan A, Rama K. RP-HPLC method development and validation for simultaneous estimation of metronidazole, clindamycine phosphate and clotrimazole in combined pharmaceutical dosage forms. Int Res J Pharm Appl Sci 2014;4(2):67-77.

Rajendar L. A stability indicating RP-HPLC method for the simultaneous estimation of metronidazole, clindamycine and clotrimazole in bulk and their combined dosage form. World J Pharm Sci 2014;3(1):93-103.

ICH. Stability Testing of New Drug Substances and Products. Geneva: International Conference on Harmonization, IFPMA; 1993.

ICH. Harmonised Tripartite Guideline, Stability Testing Of New Drug Substances and Products Q1A(R2); 2003.

ICH, Q2B. Harmonized tripartite guideline, Validation of analytical procedure Methodology. Geneva, Switzerland: International Conference on Harmonization; 1996.

ICH. Guidance on Analytical Method Validation, International Convention on Quality for the Pharmaceutical Industry. Toronto, Canada: International Conference on Harmonization; 2002.

ICH. Harmonised Triparitite Guidelines, Validation of Analytical Procedures: Text and Methodology Q2(R1); 2005.

ICH. Stability Testing: Photo stability Testing New Drug Substances and Products. Geneva: International Conference on Harmonization, IFPMA; 1996.

Mastanamma SK, Rambabu G, Saidulu P, Tejaswini IS. Designing of forced degradation studies and development of validated stability indicating method for simultaneous estimation of desloratadine and montelukast odium in their formulation. Pharm Lett 2015;7:39-47.

Masthannamma SK, Kumar TA, Srivani GB, Sridhar TA, Naik BS, Kumar VV. Stability-indicating validated reversed phase-high performance liquid chromatography method for simultaneous determination of cobicistat and atazanavir sulfate in bulk and pharmaceutical dosage form. Asian J Pharm Clin Res 2016;9(3):62-70.

Saidulu P, Mastanamma SK. Stability indicating gradient RP-HPLC method for the simultaneous estimation of lamivudine, abacavir and dolutegravir in bulk and their combined dosage form. Int J Pharm Sci Rev Res 2016;37:249-57.

Revathi Naga Lakshmi P, Prahlad P, Mastanamma SK, Ravindra N, Rao MV. UPLC separation analysis of emtricitabine, tenofovir, cobicistat and elvitegravir from their degradation products. Int J Pharm Pharm Sci 2016;8(4);362-9.

Published

01-01-2017

How to Cite

Ponnuri, R. N. L., P. Pragallapati, M. Sk, R. N, V. B. R. Mandava, B. S. N. Sudha, and K. B. Prasad. “DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING REVERSE PHASEHIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF CLINDAMYCIN, METRONIDAZOLE, AND CLOTRIMAZOLE IN PHARMACEUTICAL COMBINED DOSAGE FORMS”. Asian Journal of Pharmaceutical and Clinical Research, vol. 10, no. 1, Jan. 2017, pp. 111-7, doi:10.22159/ajpcr.2017.v10i1.14273.

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