Spectrophotometric determination of Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride by “two wavelengths method”

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Original Article

Spectrophotometric determination of Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride by “two wavelengths method”

Arun Kumar Kaura

^a,

*, Vikas Gupta

^a

, Monika Kaura

^b

, G.S. Roy

^b

, Parveen Bansal

^c

aUniversity Institute of Pharmacy, Baba Farid University of Health Sciences, Sadiq Road, Faridkot, Punjab, India

bB.I.S. College of Pharmacy, Gagra, Moga, Punjab, India

cUniversity Centre of Excellence in Research, Faridkot, Punjab, India

a r t i c l e i n f o

Article history:

Received 8 March 2013 Accepted 19 April 2013 Available online 28 May 2013

Keywords:

Principle maxima Spectral overlap

Spectrophotometric analysis UV-absorption

Wavelength range

a b s t r a c t

Background:Early methods for simultaneous determination of Chlorpheniramine Maleate (CPM) and Phenylpropanolamine Hydrochloride (PPM) in combined pharmaceutical dosage forms are expensive and time consuming methods, so this study has been performed for simultaneous determination by using UV spectrophotometer to save excessive cost and time.

Method:A rapid and simple method for simultaneous determination of Chlorpheniramine Maleate (CPM) and Phenylpropanolamine Hydrochloride (PPM) by “Two Wavelengths Method” using UV spectrophotometer has been developed in combined pharmaceutical dosage forms. “The absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest independent of interfering component”. For selection of two wavelengths for estimation of PPM at 257 nm it showed remarkable absorbance (lmax of PPM) which was noted and another point where it showed equal absorbance to that of 257 nm was reviewed over the curve and was found out as 263.6 nm. For selection of two wavelengths for estimation of CPM, at 261.6 nm (lmaxof CPM) it showed remarkable absorbance. Another point where it showed equal absorbance to that of 261.6 nm was reviewed over the curve and was found out as 253.2 nm.

Results and discussion:In the present research work an attempt has been made to develop simple method of analysis for combination of Phenylpropanolamine Hydrochloride and Chlorpheniramine Maleate as literature review revealed that no other simple reported method except HPLC, which requires sophisticated instrument and HPLC grade solvents. This method presented above utilizes the absorbance of ultraviolet radiations by PPM and CPM, distilled water was the solvent employed for this method. This method is advantageous as requires less memory capacity for storage of calibration data as well as less time consuming as compare to multicomponent analysis by other instruments.

*Corresponding author. Tel.:þ91 9888010178 (mobile).

E-mail addresses:arunkaura70@rediffmail.com,arunkaura70@gmail.com(A.K. Kaura).

Available online atwww.sciencedirect.com

journal homepage: www .e lsev ie r.com/locate/jopr

http://dx.doi.org/10.1016/j.jopr.2013.04.043

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Conclusion: The most striking features of “Two Wavelengths Method” are its simplicity, sensitivity and rapidity. It is also an easier and economical method than HPLC separation technique and does not require the use of any expensive or toxic reagent. These advantages make it especially suitable for routine quality control.

1. Introduction

Chlorpheniramine Maleate inhibits the effects of histamine on capillary permeability and bronchial smooth muscles. It is an anti-allergic drug, widely used in cough-cold preparations.

Phenylpropanolamine Hydrochloride is indirectly acting sym- pathomimetic agent and it is used in the symptomatic relief of nasal congestion. These drugs are used either alone or in combination. Besides the official methods (IP & USP) the other analytical methods available in literature for determination of Chlorpheniramine Maleate,^1e9 Phenylpropanolamine Hydro- chloride^10e17and combination of Chlorpheniramine Maleate &

Phenylpropanolamine Hydrochloride^18e20 have been menti oned. These methods are time consuming; therefore an alter- native “two wave lengths method” by UV spectrophotometry is rendered.

2. Materials and methods

The simultaneous determination of CPM and PPM is not possible by direct UV-absorption measurement method because of spectral overlap of their principle maxima. “The absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest independent of interfering component” The most striking features of “Two Wavelengths Method” are its simplicity, sensitivity and rapidity. It is also an easier and economical method than HPLC separation technique and does not require the use of any expensive or toxic reagent. These advantages make it especially suitable for routine quality control.

2.1. Materials

Authentic specimens of CPM and PPM were provided as a gift samples from M/S Plethico Pharmaceuticals, Indore.

2.2. Methods

2.2.1. Precise description of solvent and linearity studies The common solvent distilled water was used for simultaneous estimation of CPM and PPM by “Two Wavelengths Method” using UV spectrophotometer has been developed in combined pharmaceutical dosage forms. The drug solutions obey the Beer’s Law in the working range of concentrations i.e.

0e24 mcg/ml for CPM and 0e150 mcg/ml for PPM.

2.2.2. Two wavelengths calculation for tablet formulation In the normal course of analysis by two wavelength method one of the drug is considered as a component of interest and

the other drug is considered as an interfering component and vice-versa. The selected concentration combination of CPM and PPM both drugs were estimated by utilizing Two Wave- length data processing program.

2.2.3. Preparation of stock solutions

The standard solutions of CPM and PPM were prepared by weighing 25 mg of PPM and 10 mg of CPM respectively and transferred to different 100 ml volumetric flasks, each drug was dissolved in 50 ml of distilled water and finally the volume was made upto the mark with distilled water to attain 100 mcg/ml of CPM and 250 mcg/ml of PPM. From above solutions 40 mcg/ml of CPM and 250 mcg/ml of PPM solutions were prepared.

2.2.4. Selection of wavelength for estimation of CPM and PPM The solutions were scanned between 325e200 nm against blank and the maximum absorbance for PPM and CPM were found to be 257 nm and 261.6 nm respectively. The overlay spectra for both the drugs were taken by using the concentration of CPM 40 mcg/ml and PPM 250 mcg/ml. The normal overlay spectra had been shown inFig. 1.

For selection of two wavelengths for estimation of PPM, the prepared 40 mcg/ml of CPM was scanned between 325e200 nm using medium speed of scanning at 257 nm it showed remarkable absorbance (lmax of PPM) which was noted and another point where it showed equal absorbance to that of 257 nm was reviewed over the curve and was found out as 263.6 nm. These two wavelengths 257 and 263.6 nm were used for the estimation of PPM. For selection of two wavelengths for estimation of CPM, the prepared 250 mcg/ml of PPM was scanned between 325e200 nm using medium speed of scanning. At 261.6 nm (lmaxof CPM) it showed remarkable absorbance. Another point where it showed equal absorbance to that of 261.6 nm was reviewed over the curve and was found out as 253.2 nm. These two wavelengths 261.6 and 253.2 nm were used for estimation of CPM as shown inTable 1.

Fig. 1eNormal overlain spectrum of CPM and PPM.

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2.2.5. Selection of suitable standard “mixed drugs concentrations”

The mixed standards of CPM and PPM were prepared by using standard solutions of 100 mcg/ml of CPM and 250 mcg/ml of PPM using distilled water as medium. The mixed standards were prepared in 10 ml volumetric flasks as per the concentrations shown inTable 2.

2.2.6. Preparation of working calibration curve of PPM All the seven mixed standards were scanned at the respective l1andl2of PPM i.e. at 263.6 and 257 nm, in the present case CPM was interfering component so by neglecting the absorbance values for CPM the data values of absorbance difference (A1A2) corresponding to concentrations of PPM were recorded inTable 3. These mixed standards were scanned in the photometric mode of instrument.

The working calibration curve for estimation of PPM at 263.6 and 257.0 corresponding to above data is shown in the Fig. 2.

2.2.7. Preparation of working calibration curve of CPM All the seven mixed standards were scanned at the respective l1andl2for CPM i.e. at 261.6 and 253.2 nm, here PPM acted as interfering component so by neglecting the absorbance values for PPM the data values of absorbance difference (A1A2)

corresponding to concentration of CPM were recorded in Table 4. These mixed standards were scanned in the photometric mode of instrument.

The working calibration curve for estimation of CPM at 261.6 and 253.2 corresponding to above data is shown in the Fig. 3.

2.2.8. Procedure for validation of proposed method using laboratory samples

Five mixed standard solutions were prepared from standard stock solutions as shown inTable 5, these laboratory samples were used to note the absorbance difference values corresponding to PPM at 263.6 and 257.0 nm and for CPM at 261.6 and 253.2 nm. These absorbance difference values were used for estimation of CPM and PPM from standard calibration plots. Results are shown inTable 5andTable 8.

Table 1eThe wavelengths (l1,l2) selected for estimation of CPM and PPM.

S. no. Components l1 l2

(i) PPM 257.0 263.6

(ii) CPM 253.2 261.6

Table 2eThe Concentrations of CPM and PPM used for preparation of mixed standards.

S. no. Conc. of PPM mcg/ml Conc. of PPM mcg/ml

(i) 150 0

(ii) 125 4

(iii) 100 8

(iv) 75 12

(v) 50 16

(vi) 25 20

(vii) 0 24

Table 3eWorking calibration plot values for PPM at 263.6 and 257.0 nm.

S. no. Conc. of PPM mcg/ml Corresponding absorbance

(i) 0 0.00

(ii) 25 0.007

(iii) 50 0.0014

(iv) 75 0.021

(v) 100 0.028

(vi) 125 0.034

(vii) 150 0.040

Fig. 2eThe working calibration curve for estimation of PPM at 263.6 and 257.0 nm.

Table 4eWorking calibration plot values for CPM at 261.6 and 253.2 nm.

S. no. Conc. of PPM mcg/ml Corresponding absorbance

(i) 0 0.00

(ii) 4 0.008

(iii) 8 0.016

(iv) 12 0.024

(v) 16 0.033

(vi) 20 0.041

(vii) 24 0.049

Fig. 3eWorking calibration curve for estimation of CPM at 261.6 and 253.2 nm.

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2.2.9. Analysis of commercial tablet formulations

Twenty tablets were weighed and the average weight was found (243.26 mg, Labelled to claim 4 mg of CPM and 25 mg of PPM). The tablets were crushed to powder form and 243.26 mg powder was weighed and transferred to 100 ml volumetric flask. 50 ml of distilled water was added and it was shaken for 10 minutes for complete dissolution of drugs. Filtered, using Whatman filter paper no. 44. The volume was made up to mark. The final solution labelled to claim 40 mcg/ml of CPM and 250 mcg/ml of PPM. From this stock solution different dilutions were made and were used as unknown. The unknown samples were analyzed by photometric mode of instrument. The results of commercial samples are recorded in Table 6andTable 8.

2.2.10. Recovery studies

The recovery study was carried out by the addition of different concentrations of standard drugs of PPM and CPM to pre- analyzed stock solutions of commercial tablet samples as per Table 7. These samples were used to note the absorbance difference values corresponding to PPM at 263.6 and 257 nm

and for CPM at 261.6 and 253.2 nm respectively. Results are shown inTable 7andTable 8.

3. Results and discussion

In the present research work an attempt has been made to develop simple method of analysis for combination of Phen- ylpropanolamine Hydrochloride and Chlorpheniramine Ma- leate as literature review revealed that no other simple reported method except HPLC, which requires sophisticated instrument and HPLC grade solvents. This method presented above utilizes the absorbance of ultraviolet radiations by PPM and CPM, distilled water was the solvent employed for this method. This method is advantageous as requires less memory capacity for storage of calibration data as well as less time consuming as compare to multicomponent analysis by other instruments.

4. Conclusion

The “Two Wavelengths Method” using UV spectrophotometer appears to be a suitable technique for the reliable analysis of commercial formulations containing combination of CPM and PPM. The most striking features of “Two Wavelengths Method” are its simplicity, sensitivity and rapidity. It is also an easier and economical method than HPLC separation technique and does not require the use of any expensive or toxic reagent. These advantages make it especially suitable for routine quality control.

Conflicts of interest

All authors have none to declare.

Acknowledgements

The authors wish to thank Dr. Lalit Sharma, Department of Applied Sciences S.B.S. College of Engineering and Technology Ferozepur, for providing excellent research facilities for experimentation. The authors also thank M/S Plethico Phar- maceuticals for providing drug samples.

Table 5eAnalysis of authentic samples of PPM and CPM.

S. no. Expected conc.

mcg/ml

Found conc.

mcg/ml

Percent found

CPM PPM CPM PPM CPM PPM

(i) 6 70 5.9663 69.3193 99.43 99.02

(ii) 8 80 9.9158 80.4916 98.94 100.61

(iii) 10 90 10.3528 91.6639 103.52 101.84

(iv) 15 100 14.7393 99.1121 98.26 99.11

(v) 20 120 20.1006 117.7326 100.50 98.11

Table 6eAnalysis of commercial samples of CPM and PPM.

mcg/ml

Found conc.

mcg/ml

Percent found

(i) 8 50 7.915 50.6988 98.94 101.39

(ii) 12 75 12.3023 73.0434 102.51 97.39

(iii) 16 100 16.2014 99.1121 101.25 99.11

(iv) 20 125 20.1005 125.1808 100.50 100.14

(v) 24 150 24.4871 151.2495 102.02 100.83

Table 7eAnalysis of recovery studies samples of PPM and CPM.

mcg/ml

Found conc.

mcg/ml

Percent found

(i) 12 75 12.1848 74.4820 101.54 99.30

(ii) 6 50 5.8487 52.1374 97.47 104.27

(iii) 10 40 10.2352 40.9651 102.35 102.41

(iv) 8 60 8.2856 59.5520 103.57 99.25

Table 8eStatistical estimation of PPM and CPM in authentic, commercial and recovery studies samples.

Analytes Mean Standard deviation

Standard error

Co-efficient of variation Authentic samples

PPM 99.738 1.3220 0.5912 1.3255

CPM 100.13 1.8456 0.8254 1.8432

Commercial samples

PPM 99.772 1.4131 0.6319 1.4164

CPM 101.0435 1.2552 0.5613 1.2422

Recovery studies

PPM 101.3075 2.1363 1.0682 2.1087

CPM 101.2325 2.2893 1.1447 2.2614

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