INTRODUCTION:

Prochlorperazine maleate is 2-Chloro-10-[3-(4-methylpiperazin-1-yl)propyl] 10H phenothiazine bis[hydrogen(Z)-butenedioate] is antiemetic and antipsychotic drug while pyridoxine hydrochloride is 5-Hydroxy-6-methyl-3,4-pyridine dimethanol hydrochloride nutritional component.¹Prochlorperazine maleate is official in IP². Pyridoxine hydrochloride is official in IP³. IP suggests titrimetric assay of both drugs. Literature survey revealed that HPLC^4,5methods have been reported for pyridoxine hydrochloride with other drug. However, no method is reported for simultaneous estimation of these drugs in combined dosage form. This prompted us to develop simple, rapid, accurate, economical and sensitive spectrophotometric method for their combination

MATERIAL AND METHODS:

Shimadzu 1700 UV/Visible spectrophotometer with matched cuvettes was used for experimental work. The chemicals used were of analytical grade. Commercially available tablets of prochlorperazine maleate and pyridoxine hydrochloride in combination were procured from local market. Standard prochlorperazine maleate and pyridoxine hydrochloride were received as gift sample from FDA Mumbai.

Preparation of Standard Solution:

Standard stock solutions of PCM and PDH were prepared separately by dissolving 25 mg each of standard PCM and PDH in 0.3 M HCl and making up the volume up to 100 ml (250 μg/ml). Overlain spectra of standard solution of PCM and PDH were scanned between 200nm-400nm (fig.1).

Fig. 1: Overlain spectra of prochlorperazine maleate and pyridoxine hydrochloride in 0.3 M HCl. 267.5nm is the isobestic point

Pyridoxine hydrochloride showed absorption maxima at 290.5nm and prochlorperazine maleate showed at 267.5nm. Calibration curve for each drug was prepared in the concentration range of 1-5μg/ml (PCM) and 5-25 μg/ml (PDH) at corresponding wavelength i.e. 267.5 nm and 290.5 nm. Amount of each drug determined using equation as follows-

Where,

Cx and Cy are concentrations of PCM and PDH in g/100ml

QM is the ratio of absorbance of lab. mixture at 267.5nm and 290.5 nm

Qx is the ratio of absorbance of PCM at 267.5 nm and 290.5nm

Qy is the ratio of absorbance of PDH at 267.5 nm and 290.5nm

Ax₁ is the absorptivity of PCM at267.5 nm

Ay₁ is the absorptivity of PDH at 290.5 nm

A is the absorbance of combined solution at isobestic wavelength.

C x d

% Estimation = ------------- x 100

Where,

C = Cx or Cy = Concentration of PCM or PDH in g/100ml

d = Dilution factor

W = Weight of drug either PCM or PDH in laboratory mixture.

Preparation of Sample Solution:

Marketed tablets Emidoxyn Forte (Shreya Life Science Pvt Ltd., Mumbai) were used for the simultaneous estimation of PCM and PDH. Twenty tablets were weighed and crushed to fine powder. Powder equivalent to 5 mg of prochlorperazine maleate and 25 mg of pyridoxine hydrochloride was dissolved in solvent and volume was made 100 ml. Insoluble excipients were separated by filtration. The filtrate was further diluted to get final concentration of both drug in linearity range. Absorbance was noted at selected wavelengths and percent label claim was determined by using the equation.

Where,

C_xor C_y= Concentration of PCM and PDH in g/100 ml

W = Average weight of tablet

Wm = Weight of sample

L = Label claim of sample taken

Validation of Proposed Method:⁶

The reproducibility, repeatability and accuracy of the proposed method were found to be satisfactory which is evident from the low value of standard deviation (SD), percent relative standard deviation (RSD), and standard error (SE) (table 1)

The accuracy and reproducibility of the proposed method was confirmed by recovery experiment, performed by adding known amount of the drug to the preanalyzed formulation and reanalyzing the mixture by proposed method (table 2)

The percent recovery obtained indicates non-interference from the excipients used in the formulation. Thus, the method developed in the present investigation is found to be simple, sensitive, accurate and precise and can be successfully applied for the simultaneous estimation of prochlorperazine maleate and pyridoxine hydrochloride in tablets.

Table 1: Results of statistical of marketed formulation

Tablet brand

Tablet

Com-ponent

Label Claim

(mg/tab)

% SD

%RSD

Emidoxyn Forte

PCM

0.20736

0.18547

0.0344

PDH

0.76962

0.68837

0.4738

Table 2: Results of drug recovery study

Tablet brand	Amount of pure drug added (μg/ml)		% Recovery		%SD
Tablet brand	PCM	PDH	PCM	PDH	PCM	PDH
Emidoxyn Forte	1	5	99.84	100.20	0.0918	0.2027
	2	10	99.99	99.85
	3	15	100.06	100.33

ACKNOWLEDGEMENTS:

The authors wish to thank Principal Dr. K. P. Bhusari, Sharad Pawar College of Pharmacy, Rashtrasant Tukadoji Maharaj Nagpur University for providing necessary facilities. They also thank Mr. Kamlesh Shende, FDA Department, Mumbai for providing the authentic sample of drug.

REFERENCES:

1. Maryadele, S., In; The Merck Index. 13^th Edn. Merck and Co., In., Whitehouse Station, NJ, 2001, 7850, 8072.

2. Indian Pharmacopoeia, Vol. III, New Delhi. The controller of publication, Govt of India, 2011, 1972.

3. Indian Pharmacopoeia, Vol. III, New Delhi. The controller of publication, Govt of India, 2011, 2005.

4. Poongothai S, Ilavarasan R, Karrunakaran CM. Int J Pharm Pharm Sci, 2010;2(4):133-139.

5. Khor Swan-Choo and Tee E-Siong. Mal J Nutr 1996; 2:49-65.

6. International Conference on Harmonization (ICH), Draft guidelines on validation of Analytical procedure, definition and terminology, Federal Register, 1995, 60, 11260-11262.

Received on 15.06.2012 Modified on 15.07.2012

Research J. Pharm. and Tech. 5(8): August 2012; Page 1112-1113